Search

Aim. This paper is a report of the protocol for a review to identify, critically appraise and synthesize the best current evidence supporting the use of weaning protocols compared to non-protocolized practice in liberating patients from mechanical ventilation. Background. Patients experiencing difficulty in weaning require a longer hospital stay and have higher morbidity and mortality. Consequently, efforts to reduce weaning time are desirable to reduce the duration of ventilation and related complications. Standardized weaning protocols are safe and effective in reducing the time spent on mechanical ventilation. Notwithstanding, the evidence supporting their use in practice is inconsistent. The discordant results of studies may reflect the fact that protocols vary in composition and are implemented in different environments by various healthcare providers. Design. The objectives of this review are to compare the total duration of mechanical ventilation between patients weaned using protocols vs. non-protocolized practice; to ascertain differences between protocolized and non-protocolized weaning with regards to mortality, adverse events, quality of life, weaning duration, ICU and hospital stay; and to explore variation in outcomes by the type of ICU, the type of protocol and approach to delivering the protocol. We will search the Cochrane Central Register of Controlled Trials (CENTRAL) ( The Cochrane Library), MEDLINE, EMBASE, CINAHL, ISI Web of Science and LILACS. In addition, we will endeavour to identify unpublished data and contact first authors of studies included in the review to obtain information on unpublished studies or work in progress. Conclusion. This review will provide much needed direction for healthcare professionals in intensive care in terms of both research and practice. [ABSTRACT FROM AUTHOR]

Objectives: To evaluate the quality of reporting among abstracts of randomized controlled trials (RCTs) in acute lung injury and to highlight important trial information for abstract inclusion.Design: Audit of published RCT abstracts.Sample: A total of 56 RCTs, identified in MEDLINE, EMBASE, HEALTHSTAR, CINAHL, and the Cochrane Central Register of Controlled Trials.Measurements and Main Results: We used a research focus group and published literature on suggested content for abstracts of original articles to generate a list of 32 recommended items. The focus group reduced this list to a 20-item long form list of highly relevant criteria and a 12-item short form list of essential criteria for inclusion in abstracts of RCTs in acute lung injury. After pilot testing the abstract appraisal form, we evaluated abstracts independently and in duplicate. We scored the quality of reporting of each abstract by dividing the number of criteria fulfilled by the number applicable. Although abstracts described the study objectives and interventions well and the participants, outcomes, and conclusions to an intermediate extent, key deficiencies were noted in reporting the study methods, setting, and results. Mean quality of reporting scores were significantly higher for structured compared with unstructured abstracts using the 32-item, 20-item, and 12-item lists (p = .008, .014, and <.0001, respectively), especially for abstracts published after 1990 (p = .004, .017, and .001, respectively). The 20-item and 12-item lists correlated well with the 32-item list (r = .89 and .62, respectively) and with one another (r = .73).Conclusions: Key design features and results are frequently under-reported in RCT abstracts, particularly among unstructured abstracts. Checklists may aid authors and editors in prioritizing important criteria for inclusion in RCT abstracts. [ABSTRACT FROM AUTHOR]

Objective: To determine physicians' stated practices regarding the use of bilevel noninvasive ventilation (NIV) for acute respiratory failure and the predictors of practice variation.Design: Cross-sectional postal survey.Setting: Province of Ontario, Canada.Participants: Attending physicians and residents in four specialties at 15 teaching hospitals.Interventions: We used literature searches and focus groups to design questions related to NIV utilization with respect to frequency, location of and indications for use, awareness of supporting literature, and perceived efficacy. We assessed the survey's clinical sensibility and reliability. We used regression analyses to evaluate practice variation among hospitals and specialties and to determine predictors of more frequent NIV use, initiation of and continued use in nonmonitored settings, and use for specific indications.Measurements and Main Results: Three hundred eighty-five (48%) of 808 physicians responded; 242 used NIV. The two most common indications for NIV use were chronic obstructive pulmonary disease and congestive heart failure. NIV guidelines, protocols, or policies were available in 12 of 15 hospitals. We found variation in NIV utilization among specialties but not hospitals. Specialty (critical care and respirology versus internal and emergency medicine), fewer years of postgraduate experience, and a greater number of noninvasive ventilators were predictors of more frequent NIV use (all p < or = .001). Only 6% of respondents reported initiation of use and continued use most frequently in nonmonitored settings, which increased with the number of noninvasive ventilators (p = .02). Physician characteristics such as awareness of the literature were predictive of NIV use for exacerbations of chronic obstructive pulmonary disease, whereas perceived NIV efficacy was predictive of use for many indications, including congestive heart failure.Conclusions: Self-reported practice variation for bilevel NIV exists among specialties but not hospitals and differs with respect to frequency, location of use, and use for specific indications. Some factors associated with variation in NIV use may be suitable targets for utilization improvement interventions. [ABSTRACT FROM AUTHOR]

Purpose: Family members of critically ill patients spend significant periods of time in the intensive care unit (ICU) and hospital environment. We aimed to identify what services, resources, and conveniences are important to adult ICU visitors., Methods: We conducted a cross-sectional study including visitors in four adult ICUs in the province of Ontario, Canada. In the survey, we asked visitors to rate the importance of 58 items relating to the environment of patient rooms, the waiting room, and hospital facilities. For each item, we gave respondents five categorical response options, from "not at all important" to "extremely important." We used descriptive statistics to analyze the survey results., Results: We analyzed 224 surveys completed by ICU visitors (60% female, ages 14-87 yr). Respondents were predominantly children (41%) or the spouse/partner (23%) of adult ICU patients. Nearly half (51%) lived more than 30 km from the hospital, and 30% spent at least one night in the ICU waiting room, with a median of 2 nights (range, 1-20) spent in hospital. Within the hospital environment, the top four items rated as "extremely important" or "very important" were directional signage (82%), convenient parking (80%), discounted parking (80%), and healthy and affordable food (78%). Regarding ICU waiting rooms, 24/7 visitation (92%), convenient restrooms (87%), a water dispenser (83%), and Wi-Fi (80%) were priorities. Features of ICU patient rooms identified as most important included seating for visitors (92%), access to natural light (78%), and access to fresh air (74%)., Conclusions: Intensive care unit visitors prioritized pragmatic environmental elements. Many of these modifications are simple and inexpensive but may significantly improve visitors' comfort and experience., (© 2024. Canadian Anesthesiologists' Society.)

Purpose: Platypnea orthodeoxia syndrome (POS) is a rare cause of hypoxemia. Diagnosis of POS is challenging, requiring a high index of clinical suspicion, special investigations, and collaboration with multiple specialists., Clinical Features: We describe an 86-yr-old male who presented to the emergency department with hip pain after a witnessed fall. He was noted to be hypoxemic at presentation with a peripheral oxygen saturation (SpO 2 ) of 84% on room air, with an inadequate increase in oxygenation after administration of a fractional concentration of inspired oxygen (F I O 2 ) of 1.00. A chest radiograph, computed tomography pulmonary angiogram, and Doppler ultrasound of the liver were unremarkable. In the supine position with an F I O 2 of 0.65, his SpO 2 and arterial partial pressure of oxygen (PaO 2 ) (96% and 74 mm Hg, respectively) increased significantly relative to the seated position (84% and 50 mm Hg, respectively). Contrast transthoracic echocardiography (TTE) showed a large patent foramen ovale (PFO) with right-to-left shunt. Transthoracic echocardiography showed rotation of the patient's heart, enabling direct alignment of the inferior vena cava with the PFO, creating a large anatomical right-to-left shunt in the seated position. Right heart catheterization confirmed a large PFO with normal right-sided heart pressures. He was treated with a septal occlusion and his SpO 2 in the seated position improved immediately. The patient was discharged home without requiring supplemental oxygen., Conclusions: Platypnea orthodeoxia syndrome is a rare presentation of hypoxemia. Positional changes in oxygenation are the cardinal feature of POS. Discordance between lung imaging and the severity of hypoxemia should prompt investigation for an intracardiac shunt, which can occur in POS even in the absence of increased right-sided heart pressures. Either contrast TTE or transesophageal echocardiography is necessary to make this diagnosis., (© 2024. Canadian Anesthesiologists' Society.)

Importance: Extubation Advisor (EA) is a novel software tool that generates a synoptic report for each Spontaneous Breathing Trial (SBT) conducted to inform extubation decision-making., Objectives: To assess bedside EA implementation, perceptions of utility, and identify barriers and facilitators of use., Design, Setting and Participants: We conducted a phase I mixed-methods interventional study in three mixed intensive care unit (ICUs) in two academic hospitals. We interviewed critical care physicians (MDs) and respiratory therapists (RTs) regarding user-centered design principles and usability., Analysis: We evaluated our ability to consent participants (feasibility threshold 50%), capture complete data (threshold 90%), generate and review EA reports in real-time (thresholds 75% and 80%, respectively), and MD perception of tool usefulness (6-point Likert scale). We analyzed interview transcripts using inductive coding to identify facilitators and barriers to EA implementation and perceived benefit of tool use., Results: We enrolled 31 patients who underwent 70 SBTs. Although consent rates [31/31 (100%], complete data capture [68/68 (100%)], and EA report generation [68/70 (97.1%)] exceeded feasibility thresholds, reports were reviewed by MDs for [55/70 (78.6%)] SBTs. Mean MD usefulness score was 4.0/6. Based on feedback obtained from 36 interviews (15 MDs, 21 RTs), we revised the EA report twice and identified facilitators (ability to track patient progress, enhance extubation decision-making, and provide support in resource-limited settings) and barriers (resource constraints, need for education) to tool implementation. Half of respondents (9 MDs, 9 RTs; combined 50%) perceived definite or potential benefit to EA tool use., Conclusion: This is the first study of a waveform-based variability-derived, predictive clinical decision support tool evaluated in adult ICUs. Our findings support the feasibility of integrating the EA tool into bedside workflow. Clinical trials are needed to assess the utility of the EA tool in practice and its impact on extubation decision-making and outcomes., Trial Registration: NCT04708509., Competing Interests: Declaration of Conflicting InterestsDr A Seely and Dr C Herry are named on a patent related to Extubation Advisor technology described in this paper. Dr Seely is founder and board chairman of Therapeutic Monitoring Systems, a company founded to help research, develop, and commercialize clinical decision support tools based on variability analysis, including Extubation Advisor.

Importance: The optimal screening frequency and spontaneous breathing trial (SBT) technique to liberate adults from ventilators are unknown., Objective: To compare the effects of screening frequency (once-daily screening vs more frequent screening) and SBT technique (pressure-supported SBT with a pressure support level that was >0-≤8 cm H2O and a positive end-expiratory pressure [PEEP] level that was >0-≤5 cm H2O vs T-piece SBT) on the time to successful extubation., Design, Setting, and Participants: Randomized clinical trial with a 2 × 2 factorial design including critically ill adults who were receiving invasive mechanical ventilation for at least 24 hours, who were capable of initiating spontaneous breaths or triggering ventilators, and who were receiving a fractional concentration of inspired oxygen that was 70% or less and a PEEP level of 12 cm H2O or less. Recruitment was between January 2018 and February 2022 at 23 intensive care units in North America; last follow-up occurred October 18, 2022., Interventions: Participants were enrolled early to enable protocolized screening (more frequent vs once daily) to identify the earliest that patients met criteria to undergo pressure-supported or T-piece SBT lasting 30 to 120 minutes., Main Outcome and Measures: Time to successful extubation (time when unsupported, spontaneous breathing began and was sustained for ≥48 hours after extubation)., Results: Of 797 patients (198 in the once-daily screening and pressure-supported SBT group, 204 in once-daily screening and T-piece SBT, 195 in more frequent screening and pressure-supported SBT, and 200 in more frequent screening and T-piece SBT), the mean age was 62.4 (SD, 18.4) years and 472 (59.2%) were men. There were no statistically significant differences by screening frequency (hazard ratio [HR], 0.88 [95% CI, 0.76-1.03]; P = .12) or by SBT technique (HR, 1.06 [95% CI, 0.91-1.23]; P = .45). The median time to successful extubation was 2.0 days (95% CI, 1.7-2.7) for once-daily screening and pressure-supported SBT, 3.1 days (95% CI, 2.7-4.8) for once-daily screening and T-piece SBT, 3.9 days (95% CI, 2.9-4.7) for more frequent screening and pressure-supported SBT, and 2.9 days (95% CI, 2.0-3.1) for more frequent screening and T-piece SBT. An unexpected interaction between screening frequency and SBT technique required pairwise contrasts that revealed more frequent screening (vs once-daily screening) and pressure-supported SBT increased the time to successful extubation (HR, 0.70 [95% CI, 0.50-0.96]; P = .02). Once-daily screening and pressure-supported SBT (vs T-piece SBT) did not reduce the time to successful extubation (HR, 1.30 [95% CI, 0.98-1.70]; P = .08)., Conclusions and Relevance: Among critically ill adults who received invasive mechanical ventilation for more than 24 hours, screening frequency (once-daily vs more frequent screening) and SBT technique (pressure-supported vs T-piece SBT) did not change the time to successful extubation. However, an unexpected and statistically significant interaction was identified; protocolized more frequent screening combined with pressure-supported SBTs increased the time to first successful extubation., Trial Registration: ClinicalTrials.gov Identifiers: NCT02399267 and NCT02969226.

Purpose: Physical rehabilitation (PR) in the intensive care unit (ICU) may improve outcomes for survivors but clinical trial results have been discordant. We hypothesized that discordant results may reflect treatment heterogeneity received by "usual care" comparator groups in PR studies. Usual-care PR is typically underspecified, which is a barrier to comparing results across treatment studies. The primary objective of the present study was to describe the usual-care PR received by critically ill patients enrolled in the Canadian multicentre Critical Care Cycling to Improve Lower Extremity Strength (CYCLE) pilot randomized controlled trial (RCT) of PR. Other objectives were to help contextualize current research and provide data for international comparison., Methods: In this secondary analysis of the CYCLE pilot RCT, patients were randomized to in-bed cycling and usual-care PR or usual-care PR alone. Physiotherapists documented usual-care PR including therapy received, type of activity, duration, adverse events and consequences, reasons for no PR, and concurrent relevant medical interventions. We characterized usual care using descriptive statistics at the cohort and patient levels., Results: Across seven Canadian centres, 30 patients were randomized to usual-care PR. The median [interquartile range (IQR)] ICU stay was 10 [9-24] days and patients received PR on a median [IQR] of 5 [3-9] days for 23 [17-30] min per day. Eighteen patients (60%) stood, marched, or walked during usual care. Transient adverse events occurred in three patients on 1.5% (3/198) of days and none prompted session termination., Conclusions: In the usual-care arm of the CYCLE pilot RCT, PR was delivered on half of ICU days and over half of patients stood, marched, or walked. Adverse events during usual-care PR were uncommon., Study Registration: ClinicalTrials.gov ( NCT02377830 ); first posted 4 March 2015., (© 2024. Canadian Anesthesiologists' Society.)

Background: The diagnostic performance of the available risk assessment models for VTE in patients who are critically ill receiving pharmacologic thromboprophylaxis is unclear., Research Question: For patients who are critically ill receiving pharmacologic thromboprophylaxis, do risk assessment models predict who would develop VTE or who could benefit from adjunctive pneumatic compression for thromboprophylaxis?, Study Design and Methods: In this post hoc analysis of the Pneumatic Compression for Preventing VTE (PREVENT) trial, different risk assessment models for VTE (ICU-VTE, Kucher, Intermountain, Caprini, Padua, and International Medical Prevention Registry on VTE [IMPROVE] models) were evaluated. Receiver-operating characteristic curves were constructed, and the sensitivity, specificity, positive and negative predictive values, and positive and negative likelihood ratios were calculated. In addition, subgroup analyses were performed evaluating the effect of adjunctive pneumatic compression vs none on the study primary outcome., Results: Among 2,003 patients receiving pharmacologic thromboprophylaxis, 198 (9.9%) developed VTE. With multivariable logistic regression analysis, the independent predictors of VTE were Acute Physiology and Chronic Health Evaluation II score, prior immobilization, femoral central venous catheter, and invasive mechanical ventilation. All risk assessment models had areas under the curve < 0.60 except for the Caprini model (0.64; 95% CI, 0.60-0.68). The Caprini, Padua, and Intermountain models had high sensitivity (> 85%) but low specificity (< 20%) for predicting VTE, whereas the ICU-VTE, Kucher, and IMPROVE models had low sensitivities (< 15%) but high specificities (> 85%). The positive predictive value was low (< 20%) for all studied cutoff scores, whereas the negative predictive value was mostly > 90%. Using the risk assessment models to stratify patients into high- vs low-risk subgroups, the effect of adjunctive pneumatic compression vs pharmacologic prophylaxis alone did not differ across the subgroups (P interaction > .05)., Interpretation: The risk assessment models for VTE performed poorly in patients who are critically ill receiving pharmacologic thromboprophylaxis. None of the models identified a subgroup of patients who might benefit from adjunctive pneumatic compression., Clinical Trial Registration: ClinicalTrials.gov; No.: NCT02040103; URL: www., Clinicaltrials: gov. ISRCTN44653506., Competing Interests: Financial/Nonfinancial Disclosures None declared., (Copyright © 2024 American College of Chest Physicians. Published by Elsevier Inc. All rights reserved.)

Purpose: Equity, Diversity, and Inclusion (EDI) initiatives within critical care research are limited by a lack of resources and inconsistent and rapidly changing language. The Canadian Critical Care Trials Group (CCCTG) is committed to modelling EDI for the critical care community through its programming, communications, protocols, and policies. The objective of developing the EDI glossary of sociodemographic determinants of health described here was to provide a resource for critical care professionals to support broader equity initiatives and to promote education and awareness about inclusive language., Methods: Through literature review, we identified EDI-related sociodemographic determinants of health, defined as sociodemographic factors that are associated with disparities in health care and health outcomes, with a focus on critical care medicine. For each sociodemographic determinant of health, we identified umbrella terms (defined as domains) and subterms/constructs that are related to these domains. We designed the glossary collaboratively with the CCCTG EDI working group, patient and family partnerships committee, and executive committee, which included diverse knowledge users such as researchers, clinicians, and patient and family partners., Results: We report on 12 sociodemographic determinants of health domains including age, sex, gender, sexuality, race and ethnicity, income, education, employment status, marital status, language, disability, and migration status. Each domain (e.g., sex) contains relevant subterms such as male, female, intersex. For each domain, we provide examples of disparities in health care and health outcomes with a focus on critical care medicine., Conclusions: This EDI glossary of sociodemographic determinants of health serves as a nonexhaustive resource that may be referenced by critical care researchers, research coordinators, clinicians, and patient and family partners. The glossary is an essential step to raising awareness about inclusive terminology and to fostering and advancing equity in critical care medicine., (© 2024. Canadian Anesthesiologists' Society.)

Rationale: Women, older individuals, and racial and ethnic minority groups are often underrepresented in research studies. Objectives: We evaluated the demographics and diversity of participants enrolled in randomized controlled trials (RCTs) and observational studies published by investigators in association with the Canadian Critical Care Trials Group. Methods: We performed quantitative content analysis of peer-reviewed RCTs and observational studies from December 1994 to December 2022. For each publication, we extracted participant demographic variables, including sex, gender, age, race or ethnicity, sexual orientation, pregnancy status, language proficiency, income/financial status, housing, education, disability, and geography. Results: A total of 120 publications (28 RCTs, 92 observational studies) included 211,144 enrolled participants. Most (107 of 120; 89.2%) were multicenter studies, and 70% (84 of 120) were conducted exclusively in Canadian centers; 77.5% (93 of 120) studies enrolled adult participants, and 19.2% (23 of 120) enrolled pediatric participants. All studies reported participant mean or median age, 118 (98.3%) reported binary sex or gender, and 9 (7.5%) reported race or ethnicity. No justification was provided in 35 studies that listed pregnancy as an exclusion. There was infrequent reporting of housing ( n  = 4), employment ( n  = 2), income ( n  = 2), and education ( n  = 1). No studies reported the language proficiency, sexual orientation, disability, or geography of participants. Of the studies reporting gender, women and/or girls comprised 42.3% participants (range, 8.9-67.7%). Within nine studies reporting race or ethnicity of 2,950 participants, 59.7% were White, 8% South Asian, 7% Indigenous, 3% Asian, 1% Black, 14% unknown, and 6% "other." Conclusions: Research publications from the Canadian Critical Care Trials Group infrequently report important participant demographics, and diversity of research participants is disproportionate compared with Canadian societal demographics.

Although current clinical practice guidelines have discordant conclusions, a judicious approach to using NMBA infusions may include reserving their use for patients with early severe ARDS who are already deeply sedated and for patients under light sedation who have significant ventilator dyssynchrony, despite attempts to adjust both ventilator settings and sedation requirements. Based on current evidence, the duration of NMBA use should be limited to 48 hours, whenever possible., Competing Interests: Disclosure Drs K.E.A. Burns and S.N. Myatra have no financial or nonfinancial conflicts of interest to disclose., (Copyright © 2024 Elsevier Inc. All rights reserved.)

Background: The effect of a liberal transfusion strategy as compared with a restrictive strategy on outcomes in critically ill patients with traumatic brain injury is unclear., Methods: We randomly assigned adults with moderate or severe traumatic brain injury and anemia to receive transfusion of red cells according to a liberal strategy (transfusions initiated at a hemoglobin level of ≤10 g per deciliter) or a restrictive strategy (transfusions initiated at ≤7 g per deciliter). The primary outcome was an unfavorable outcome as assessed by the score on the Glasgow Outcome Scale-Extended at 6 months, which we categorized with the use of a sliding dichotomy that was based on the prognosis of each patient at baseline. Secondary outcomes included mortality, functional independence, quality of life, and depression at 6 months., Results: A total of 742 patients underwent randomization, with 371 assigned to each group. The analysis of the primary outcome included 722 patients. The median hemoglobin level in the intensive care unit was 10.8 g per deciliter in the group assigned to the liberal strategy and 8.8 g per deciliter in the group assigned to the restrictive strategy. An unfavorable outcome occurred in 249 of 364 patients (68.4%) in the liberal-strategy group and in 263 of 358 (73.5%) in the restrictive-strategy group (adjusted absolute difference, restrictive strategy vs. liberal strategy, 5.4 percentage points; 95% confidence interval, -2.9 to 13.7). Among survivors, a liberal strategy was associated with higher scores on some but not all the scales assessing functional independence and quality of life. No association was observed between the transfusion strategy and mortality or depression. Venous thromboembolic events occurred in 8.4% of the patients in each group, and acute respiratory distress syndrome occurred in 3.3% and 0.8% of patients in the liberal-strategy and restrictive-strategy groups, respectively., Conclusions: In critically ill patients with traumatic brain injury and anemia, a liberal transfusion strategy did not reduce the risk of an unfavorable neurologic outcome at 6 months. (Funded by the Canadian Institutes of Health Research and others; HEMOTION ClinicalTrials.gov number, NCT03260478.)., (Copyright © 2024 Massachusetts Medical Society.)

Introduction: Sociodemographic variables influence health outcomes, either directly (ie, gender identity) or indirectly (eg, structural/systemic racism based on ethnoracial group). Identification of how sociodemographic variables can impact the health of critically ill adults is important to guide care and research design for this population. However, despite the growing recognition of the importance of collecting sociodemographic measures that influence health outcomes, insufficient and inconsistent data collection of sociodemographic variables persists in critical care studies. We aim to develop a set of core data variables (CoDaV) for social determinants of health specific to studies involving critically ill adults., Methods and Analysis: We will conduct a scoping review to generate a list of possible sociodemographic measures to be used for round 1 of the modified Delphi processes. We will engage relevant knowledge users (previous intensive care unit patients and family members, critical care researchers, critical care clinicians and research co-ordinators) to participate in the modified Delphi consensus survey to identify the CoDaV. A final consensus meeting will be held with knowledge user representatives to discuss the final CoDaV, how each sociodemographic variable will be collected (eg, level of granularity) and how to disseminate the CoDaV for use in critical care studies., Ethics and Dissemination: The University of Calgary conjoint health research ethics board has approved this study protocol (REB22-1648)., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Background: Whether proton-pump inhibitors are beneficial or harmful for stress ulcer prophylaxis in critically ill patients undergoing invasive ventilation is unclear., Methods: In this international, randomized trial, we assigned critically ill adults who were undergoing invasive ventilation to receive intravenous pantoprazole (at a dose of 40 mg daily) or matching placebo. The primary efficacy outcome was clinically important upper gastrointestinal bleeding in the intensive care unit (ICU) at 90 days, and the primary safety outcome was death from any cause at 90 days. Multiplicity-adjusted secondary outcomes included ventilator-associated pneumonia, Clostridioides difficile infection, and patient-important bleeding., Results: A total of 4821 patients underwent randomization in 68 ICUs. Clinically important upper gastrointestinal bleeding occurred in 25 of 2385 patients (1.0%) receiving pantoprazole and in 84 of 2377 patients (3.5%) receiving placebo (hazard ratio, 0.30; 95% confidence interval [CI], 0.19 to 0.47; P<0.001). At 90 days, death was reported in 696 of 2390 patients (29.1%) in the pantoprazole group and in 734 of 2379 patients (30.9%) in the placebo group (hazard ratio, 0.94; 95% CI, 0.85 to 1.04; P = 0.25). Patient-important bleeding was reduced with pantoprazole; all other secondary outcomes were similar in the two groups., Conclusions: Among patients undergoing invasive ventilation, pantoprazole resulted in a significantly lower risk of clinically important upper gastrointestinal bleeding than placebo, with no significant effect on mortality. (Funded by the Canadian Institutes of Health Research and others; REVISE ClinicalTrials.gov number, NCT03374800.)., (Copyright © 2024 Massachusetts Medical Society.)

Background: Critical illness requiring invasive mechanical ventilation can precipitate important functional disability, contributing to multidimensional morbidity following admission to an intensive care unit (ICU). Early in-bed cycle ergometry added to usual physiotherapy may mitigate ICU-acquired physical function impairment., Methods: We randomly assigned 360 adult ICU patients undergoing invasive mechanical ventilation to receive 30 minutes of early in-bed Cycling + Usual physiotherapy (n=178) or Usual physiotherapy alone (n=182). The primary outcome was the Physical Function ICU Test-scored (PFIT-s) at 3 days after discharge from the ICU (the score ranges from 0 to 10, with higher scores indicating better function)., Results: Cycling began within a median (interquartile range) of 2 (1 to 3) days of starting mechanical ventilation; patients received 3 (2 to 5) cycling sessions for a mean (±standard deviation) of 27.2 ± 6.6 minutes. In both groups, patients started Usual physiotherapy within 2 (2 to 4) days of mechanical ventilation and received 4 (2 to 7) Usual physiotherapy sessions. The duration of Usual physiotherapy was 23.7 ± 15.1 minutes in the Cycling + Usual physiotherapy group and 29.1 ± 13.2 minutes in the Usual physiotherapy group. No serious adverse events occurred in either group. Among survivors, the PFIT-s at 3 days after discharge from the ICU was 7.7 ± 1.7 in the Cycling + Usual physiotherapy group and 7.5 ± 1.7 in the Usual physiotherapy group (absolute difference, 0.23 points; 95% confidence interval, -0.19 to 0.65; P=0.29)., Conclusions: Among adults receiving mechanical ventilation in the ICU, adding early in-bed Cycling to usual physiotherapy did not improve physical function at 3 days after discharge from the ICU compared with Usual physiotherapy alone. Cycling did not cause any serious adverse events. (Funded by the Canadian Institutes of Health Research and others; ClinicalTrials.gov numbers, NCT03471247 [full randomized clinical trial] and NCT02377830 [CYCLE Vanguard 46-patient internal pilot].).

Importance: The COVID-19 pandemic created unprecedented challenges for clinical trials worldwide, threatening premature closure and trial integrity. Every phase of research operations was affected, often requiring modifications to protocol design and implementation., Objectives: To identify the barriers, solutions, and opportunities associated with continuing critical care trials that were interrupted during the pandemic, and to generate suggestions for future trials., Design, Setting, and Participants: This mixed-methods study performed an explanatory sequential analysis involving a self-administered electronic survey and focus groups of principal investigators (PIs) and project coordinators (PCs) conducting adult and pediatric individual-patient randomized trials of the Canadian Critical Care Trials Group during the COVID-19 pandemic. Eligible trials were actively enrolling patients on March 11, 2020. Data were analyzed between September 2023 and January 2024., Main Outcomes and Measures: Importance ratings of barriers to trial conduct and completion, solutions employed, opportunities arising, and suggested strategies for future trials. Quantitative data examining barriers were analyzed using descriptive statistics. Data addressing solutions, opportunities, and suggestions were analyzed by qualitative content analysis. Integration involved triangulation of data sources and perspectives about 13 trials, synthesized by an interprofessional team incorporating reflexivity and member-checking., Results: A total of 13 trials run by 29 PIs and PCs (100% participation rate) were included. The highest-rated barriers (on a 5-point scale) to ongoing conduct during the pandemic were decisions to pause all clinical research (mean [SD] score, 4.7 [0.8]), focus on COVID-19 studies (mean [SD] score, 4.6 [0.8]), and restricted family presence in hospitals (mean [SD] score, 4.1 [0.8]). Suggestions to enable trial progress and completion included providing scientific leadership, implementing technology for communication and data management, facilitating the informed consent process, adapting the protocol as necessary, fostering site engagement, initiating new sites, streamlining ethics and contract review, and designing nested studies. The pandemic necessitated new funding opportunities to sustain trial enrollment. It increased public awareness of critical illness and the importance of randomized trial evidence., Conclusions and Relevance: While underscoring the vital role of research in society and drawing the scientific community together with a common purpose, the pandemic signaled the need for innovation to ensure the rigor and completion of ongoing trials. Lessons learned to optimize research procedures will help to ensure a vibrant clinical trials enterprise in the future.

Objectives: To review recruitment and retention strategies of randomized family-centered interventional studies in adult ICUs., Data Sources: The MEDLINE, Embase, PsycINFO, CINAHL, and the Cochrane Library database from inception to February 2023., Study Selection: Randomized controlled trials with family-centered interventions in the ICU setting that reported at least one family-centered outcome that were included in our previously published systematic review., Data Extraction: For recruitment: Number of family members approached and enrolled, type of approach, location, time of day approached, whether medical team approached first, compensation offered, and type of consent. For retention: Number of family members enrolled and completed initial follow-up visit, mode of follow-up, location of follow-up visit, data collection method, timing of follow-up visits, number of follow-up visits, and compensation offered. Recruitment (participants approached/enrolled) and retention (participants enrolled/completed initial follow-up) percentage were calculated., Data Synthesis: There were 51 studies in the analysis. The mean recruitment percentage was 49.3% ± 24.3%. There were no differences in recruitment percentage by study country, ICU type, recruitment approach, or whether the medical team approached the family member first (all p > 0.05). The mean retention percentage for the initial follow-up visit was 81.6% ± 18.0%. There were no differences in retention percentage by mode of participant contact, data collection type, or follow-up location (all p > 0.05). Minimal data were available to determine the impact of time of day approached and compensation on recruitment and retention outcomes., Conclusions: About half of family members of ICU patients approached participated in trials and more than eight in ten completed the initial follow-up visit. We did not identify specific factors that impacted family recruitment or retention. There is a strong need for further studies to characterize optimal strategies to ensure family participation in clinical trials., Competing Interests: Dr. Goldfarb is supported by a Clinical Research Award from the Fonds de Recherche du Québec—Santé. The remaining authors have disclosed that they do not have any potential conflicts of interest., (Copyright © 2024 The Authors. Published by Wolters Kluwer Health, Inc. on behalf of the Society of Critical Care Medicine.)

Introduction: Most solid organ transplants originate from donors meeting criteria for death by neurological criteria (DNC). Within the organ donor, physiological responses to brain death increase the risk of ischaemia reperfusion injury and delayed graft function. Donor preconditioning with calcineurin inhibition may reduce this risk., Methods and Analysis: We designed a multicentre placebo-controlled pilot randomised trial involving nine organ donation hospitals and all 28 transplant programmes in the Canadian provinces of Ontario and Québec. We planned to enrol 90 DNC donors and their approximately 324 organ recipients, totalling 414 participants. Donors receive an intravenous infusion of either tacrolimus 0.02 mg/kg over 4 hours prior to organ retrieval, or a matching placebo, while monitored in an intensive care unit for any haemodynamic changes during the infusion. Among all study organ recipients, we record measures of graft function for the first 7 days in hospital and we will record graft survival after 1 year. We examine the feasibility of this trial with respect to the proportion of all eligible donors enrolled and the proportion of all eligible transplant recipients consenting to receive a CINERGY organ transplant and to allow the use of their health data for study purposes. We will report these feasibility outcomes as proportions with 95% CIs. We also record any barriers encountered in the launch and in the implementation of this trial with detailed source documentation., Ethics and Dissemination: We will disseminate trial results through publications and presentations at participating sites and conferences. This study has been approved by Health Canada (HC6-24-c241083) and by the Research Ethics Boards of all participating sites and in Québec (MP-31-2020-3348) and Clinical Trials Ontario (Project #3309)., Trial Registration Number: NCT05148715., Competing Interests: Competing interests: CL, FDA, FLam, FLau, F-MC and MC are recipients of research career awards from the Fonds de recherche du Québec-Santé. AFT is the chairholder of the Canada Research Chair in Critical Care Neurology and Trauma. FDA, MW and PC received stipends for their role at Transplant Québec MaS holds research grants from the Canadian Institute of Health Research and the New Frontiers in Research Fund related to organ donation research and received a stipend for his role as the Regional Medical Lead (Donation) from Ontario Health (Trillium Gift of Life Network). MSe, RB, M-HM, MMa, A-JF, BB, AD, EC, SHo, LB, HT, PL, JGB, MKS, KEAB, JZ, SE, GK, AH, SHa, BR, SJWO, DT and MMe declare no competing interests., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Background: The spontaneous breathing trial (SBT) technique that best balance successful extubation with the risk for reintubation is unknown. We sought to determine the comparative efficacy and safety of alternative SBT techniques., Methods: We searched Medline, EMBASE, and the Cochrane Central Register of Controlled Trials from inception to February 2023 for randomized or quasi-randomized trials comparing SBT techniques in critically ill adults and children and reported initial SBT success, successful extubation, reintubation (primary outcomes) and mortality (ICU, hospital, most protracted; secondary outcome) rates. Two reviewers screened, reviewed full-texts, and abstracted data. We performed frequentist random-effects network meta-analysis., Results: We included 40 RCTs (6716 patients). Pressure Support (PS) versus T-piece SBTs was the most common comparison. Initial successful SBT rates were increased with PS [risk ratio (RR) 1.08, 95% confidence interval (CI) (1.05-1.11)], PS/automatic tube compensation (ATC) [1.12 (1.01 -1.25), high flow nasal cannulae (HFNC) [1.07 (1.00-1.13) (all moderate certainty), and ATC [RR 1.11, (1.03-1.20); low certainty] SBTs compared to T-piece SBTs. Similarly, initial successful SBT rates were increased with PS, ATC, and PS/ATC SBTs compared to continuous positive airway pressure (CPAP) SBTs. Successful extubation rates were increased with PS [RR 1.06, (1.03-1.09); high certainty], ATC [RR 1.13, (1.05-1.21); moderate certainty], and HFNC [RR 1.06, (1.02-1.11); high certainty] SBTs, compared to T-piece SBTs. There was little to no difference in reintubation rates with PS (vs. T-piece) SBTs [RR 1.05, (0.91-1.21); low certainty], but increased reintubation rates with PS [RR 2.84, (1.61-5.03); moderate certainty] and ATC [RR 2.95 (1.57-5.56); moderate certainty] SBTs compared to HFNC SBTs., Conclusions: SBTs conducted with pressure augmentation (PS, ATC, PS/ATC) versus without (T-piece, CPAP) increased initial successful SBT and successful extubation rates. Although SBTs conducted with PS or ATC versus HFNC increased reintubation rates, this was not the case for PS versus T-piece SBTs., (© 2024. The Author(s).)

Introduction: The objective of this study was to create a definition of patient-important upper gastrointestinal bleeding during critical illness as an outcome for a randomized trial., Design: This was a sequential mixed-methods qualitative-dominant multi-center study with an instrument-building aim. In semi-structured individual interviews or focus groups we elicited views from survivors of critical illness and family members of patients in the intensive care unit (ICU) regarding which features indicate important gastrointestinal bleeding. Quantitative demographic characteristics were collected. We analyzed qualitative data using inductive content analysis to develop a definition for patient-important upper gastrointestinal bleeding., Setting: Canada and the United States., Participants: 51 ICU survivors and family members of ICU patients., Results: Participants considered gastrointestinal bleeding to be important if it resulted in death, disability, or prolonged hospitalization. The following also signaled patient-important upper gastrointestinal bleeding: blood transfusion, vasopressors, endoscopy, CT-angiography, or surgery. Whether an intervention evinced concern depended on its effectiveness, side-effects, invasiveness and accessibility; contextual influences included participant familiarity and knowledge of interventions and trust in the clinical team., Conclusions: Survivors of critical illness and family members described patient-important upper gastrointestinal bleeding differently than current definitions of clinically-important upper gastrointestinal bleeding., Competing Interests: Declaration of competing interest N/A., (Copyright © 2024 The Authors. Published by Elsevier Inc. All rights reserved.)

Background: Effective mentorship is an important contributor to academic success. Given the critical role of leadership in fostering mentorship, this study sought to explore the perspectives of departmental leadership regarding 1) current departmental mentorship processes; and 2) crucial components of a mentorship program that would enhance the effectiveness of mentorship., Methods: Department Division Directors (DDDs), Vice-Chairs, and Mentorship Facilitators from the Department of Medicine at the University of Toronto Temerty Faculty of Medicine were interviewed between April and December 2021 using a semi-structured guide. Interviews were audio-recorded and transcribed verbatim, then coded. Analysis occurred in 2 steps: 1) codes were organized to identify emergent themes; then 2) the Social Ecological Model (SEM) was applied to interpret the findings., Results: Nineteen interviews (14 DDDs, 3 Vice-Chairs, and 2 Mentorship Facilitator) were completed. Analysis revealed three themes: (1) a culture of mentorship permeated the department as evidenced by rigorous mentorship processes, divisional mentorship innovations, and faculty that were keen to mentor; (2) barriers to the establishment of effective mentoring relationships existed at 3 levels: departmental, interpersonal (mentee-mentor relationships), and mentee; and (3) strengthening the culture of mentorship could entail scaling up pre-existing mentorship processes and promoting faculty engagement. Application of SEM highlighted critical program features and determined that two components of interventions (creating tools to measure mentorship outcomes and systems for mentor recognition) were potential enablers of success., Conclusions: Establishing 'mentorship outcome measures' can incentivize and maintain relationships. By tangibly delineating departmental expectations for mentorship and creating systems that recognize mentors, these measures can contribute to a culture of mentorship., (© 2024. The Author(s).)

Objective: To characterise sex and gender-based analysis (SGBA) and diversity metric reporting, representation of female/women participants in acute care trials and temporal changes in reporting before and after publication of the 2016 Sex and Gender Equity in Research guideline., Design: Systematic review., Data Sources: We searched MEDLINE for trials published in five leading medical journals in 2014, 2018 and 2020., Study Selection: Trials that enrolled acutely ill adults, compared two or more interventions and reported at least one clinical outcome., Data Abstraction and Synthesis: 4 reviewers screened citations and 22 reviewers abstracted data, in duplicate. We compared reporting differences between intensive care unit (ICU) and cardiology trials., Results: We included 88 trials (75 (85.2%) ICU and 13 (14.8%) cardiology) (n=111 428; 38 140 (34.2%) females/women). Of 23 (26.1%) trials that reported an SGBA, most used a forest plot (22 (95.7%)), were prespecified (21 (91.3%)) and reported a sex-by-intervention interaction with a significance test (19 (82.6%)). Discordant sex and gender terminology were found between headings and subheadings within baseline characteristics tables (17/32 (53.1%)) and between baseline characteristics tables and SGBA (4/23 (17.4%)). Only 25 acute care trials (28.4%) reported race or ethnicity. Participants were predominantly white (78.8%) and male/men (65.8%). No trial reported gendered-social factors. SGBA reporting and female/women representation did not improve temporally. Compared with ICU trials, cardiology trials reported significantly more SGBA (15/75 (20%) vs 8/13 (61.5%) p=0.005)., Conclusions: Acute care trials in leading medical journals infrequently included SGBA, female/women and non-white trial participants, reported race or ethnicity and never reported gender-related factors. Substantial opportunity exists to improve SGBA and diversity metric reporting and recruitment of female/women participants in acute care trials., Prospero Registration Number: CRD42022282565., Competing Interests: Competing interests: All authors have completed the ICMJE uniform disclosure form at http://www.icmje.org/disclosure-of-interest/. EB-C has received investigator-initiated grant funding from Bayer, BMS-Pfizer and Roche Diagnostics and consulting honoraria from Trimedic Therapeutics, which were unrelated to the current work. JR is a co-methodologist on the Society of Critical Care Medicine Guideline Committee–End of Life Care in the ICU Guidelines. VP is a member of the Canadian Critical Care Society–Equity, Diversity, Decolonisation and Inclusion Committee. KEAB is President of the Canadian Critical Care Society and an Ex-officio member of the Canadian Critical Care Trials Group Executive Committee. There are no other relationships or activities that could appear to have influenced the submitted work., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Purpose: Assessing efficacy of electrical impedance tomography (EIT) in optimizing positive end-expiratory pressure (PEEP) for acute respiratory distress syndrome (ARDS) patients to enhance respiratory system mechanics and prevent ventilator-induced lung injury (VILI), compared to traditional methods., Methods: We carried out a systematic review and meta-analysis, spanning literature from January 2012 to May 2023, sourced from Scopus, PubMed, MEDLINE (Ovid), Cochrane, and LILACS, evaluated EIT-guided PEEP strategies in ARDS versus conventional methods. Thirteen studies (3 randomized, 10 non-randomized) involving 623 ARDS patients were analyzed using random-effects models for primary outcomes (respiratory mechanics and mechanical power) and secondary outcomes (PaO 2 /FiO 2 ratio, mortality, stays in intensive care unit (ICU), ventilator-free days)., Results: EIT-guided PEEP significantly improved lung compliance (n = 941 cases, mean difference (MD) = 4.33, 95% confidence interval (CI) [2.94, 5.71]), reduced mechanical power (n = 148, MD = - 1.99, 95% CI [- 3.51, - 0.47]), and lowered driving pressure (n = 903, MD = - 1.20, 95% CI [- 2.33, - 0.07]) compared to traditional methods. Sensitivity analysis showed consistent positive effect of EIT-guided PEEP on lung compliance in randomized clinical trials vs. non-randomized studies pooled (MD) = 2.43 (95% CI - 0.39 to 5.26), indicating a trend towards improvement. A reduction in mortality rate (259 patients, relative risk (RR) = 0.64, 95% CI [0.45, 0.91]) was associated with modest improvements in compliance and driving pressure in three studies., Conclusions: EIT facilitates real-time, individualized PEEP adjustments, improving respiratory system mechanics. Integration of EIT as a guiding tool in mechanical ventilation holds potential benefits in preventing ventilator-induced lung injury. Larger-scale studies are essential to validate and optimize EIT's clinical utility in ARDS management., (© 2024. The Author(s).)

Background: Various studies have demonstrated gender disparities in workplace settings and the need for further intervention. This study identifies and examines evidence from randomized controlled trials (RCTs) on interventions examining gender equity in workplace or volunteer settings. An additional aim was to determine whether interventions considered intersection of gender and other variables, including PROGRESS-Plus equity variables (e.g., race/ethnicity)., Methods: Scoping review conducted using the JBI guide. Literature was searched in MEDLINE, Embase, PsycINFO, CINAHL, Web of Science, ERIC, Index to Legal Periodicals and Books, PAIS Index, Policy Index File, and the Canadian Business & Current Affairs Database from inception to May 9, 2022, with an updated search on October 17, 2022. Results were reported using Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension to scoping reviews (PRISMA-ScR), Sex and Gender Equity in Research (SAGER) guidance, Strengthening the Integration of Intersectionality Theory in Health Inequality Analysis (SIITHIA) checklist, and Guidance for Reporting Involvement of Patients and the Public (GRIPP) version 2 checklist. All employment or volunteer sectors settings were included. Included interventions were designed to promote workplace gender equity that targeted: (a) individuals, (b) organizations, or (c) systems. Any comparator was eligible. Outcomes measures included any gender equity related outcome, whether it was measuring intervention effectiveness (as defined by included studies) or implementation. Data analyses were descriptive in nature. As recommended in the JBI guide to scoping reviews, only high-level content analysis was conducted to categorize the interventions, which were reported using a previously published framework., Results: We screened 8855 citations, 803 grey literature sources, and 663 full-text articles, resulting in 24 unique RCTs and one companion report that met inclusion criteria. Most studies (91.7%) failed to report how they established sex or gender. Twenty-three of 24 (95.8%) studies reported at least one PROGRESS-Plus variable: typically sex or gender or occupation. Two RCTs (8.3%) identified a non-binary gender identity. None of the RCTs reported on relationships between gender and other characteristics (e.g., disability, age, etc.). We identified 24 gender equity promoting interventions in the workplace that were evaluated and categorized into one or more of the following themes: (i) quantifying gender impacts; (ii) behavioural or systemic changes; (iii) career flexibility; (iv) increased visibility, recognition, and representation; (v) creating opportunities for development, mentorship, and sponsorship; and (vi) financial support. Of these interventions, 20/24 (83.3%) had positive conclusion statements for their primary outcomes (e.g., improved academic productivity, increased self-esteem) across heterogeneous outcomes., Conclusions: There is a paucity of literature on interventions to promote workplace gender equity. While some interventions elicited positive conclusions across a variety of outcomes, standardized outcome measures considering specific contexts and cultures are required. Few PROGRESS-Plus items were reported. Non-binary gender identities and issues related to intersectionality were not adequately considered. Future research should provide consistent and contemporary definitions of gender and sex., Trial Registration: Open Science Framework https://osf.io/x8yae ., (© 2024. The Author(s).)

Increasing evidence supports specific approaches to liberate patients from invasive ventilation including the use of liberation protocols, inspiratory assistance during spontaneous breathing trials (SBTs), early extubation of patients with chronic obstructive pulmonary disease to noninvasive ventilation, and prophylactic use of noninvasive support strategies after extubation. Additional research is needed to elucidate the best criteria to identify patients who are ready to undergo an SBT and to inform optimal screening frequency, the best SBT technique and duration, extubation assessments, and extubation decision-making. Additional clarity is also needed regarding the optimal timing to measure and report extubation success., Competing Interests: Disclosure K.E.A. Burns holds a Canadian Institutes of Health Research grant to investigate weaning strategies and Physician Services Incorporated Mid Career Research Award. A.J. Seely is the founder and CEO of Therapeutic Monitoring Systems, which holds global licensing rights for intellectual property related to Extubation Advisor (a tool designed to aid extubation assessment) and tools being developed in the Ottawa Hospital Research Institute Dynamical Analysis Laboratory that require regulatory approval and commercialization for bedside application. B. Rochwerg has no conflicts of interest to declare., (Copyright © 2024 Elsevier Inc. All rights reserved.)

Background : The ability to predict a long duration of mechanical ventilation (MV) by clinicians is very limited. We assessed the value of machine learning (ML) for early prediction of the duration of MV > 14 days in patients with moderate-to-severe acute respiratory distress syndrome (ARDS). Methods : This is a development, testing, and external validation study using data from 1173 patients on MV ≥ 3 days with moderate-to-severe ARDS. We first developed and tested prediction models in 920 ARDS patients using relevant features captured at the time of moderate/severe ARDS diagnosis, at 24 h and 72 h after diagnosis with logistic regression, and Multilayer Perceptron, Support Vector Machine, and Random Forest ML techniques. For external validation, we used an independent cohort of 253 patients on MV ≥ 3 days with moderate/severe ARDS. Results : A total of 441 patients (48%) from the derivation cohort (n = 920) and 100 patients (40%) from the validation cohort (n = 253) were mechanically ventilated for >14 days [median 14 days (IQR 8-25) vs. 13 days (IQR 7-21), respectively]. The best early prediction model was obtained with data collected at 72 h after moderate/severe ARDS diagnosis. Multilayer Perceptron risk modeling identified major prognostic factors for the duration of MV > 14 days, including PaO 2 /FiO 2 , PaCO 2 , pH, and positive end-expiratory pressure. Predictions of the duration of MV > 14 days showed modest discrimination [AUC 0.71 (95%CI 0.65-0.76)]. Conclusions : Prolonged MV duration in moderate/severe ARDS patients remains difficult to predict early even with ML techniques such as Multilayer Perceptron and using data at 72 h of diagnosis. More research is needed to identify markers for predicting the length of MV. This study was registered on 14 August 2023 at ClinicalTrials.gov (NCT NCT05993377).

The aim of this Intensive Care Medicine Rapid Practice Guideline (ICM-RPG) was to provide evidence-based clinical guidance about the use of higher versus lower oxygenation targets for adult patients in the intensive care unit (ICU). The guideline panel comprised 27 international panelists, including content experts, ICU clinicians, methodologists, and patient representatives. We adhered to the methodology for trustworthy clinical practice guidelines, including the use of the Grading of Recommendations Assessment, Development, and Evaluation approach to assess the certainty of evidence, and used the Evidence-to-Decision framework to generate recommendations. A recently published updated systematic review and meta-analysis constituted the evidence base. Through teleconferences and web-based discussions, the panel provided input on the balance and magnitude of the desirable and undesirable effects, the certainty of evidence, patients' values and preferences, costs and resources, equity, feasibility, acceptability, and research priorities. The updated systematic review and meta-analysis included data from 17 randomized clinical trials with 10,248 participants. There was little to no difference between the use of higher versus lower oxygenation targets for all outcomes with available data, including all-cause mortality, serious adverse events, stroke, functional outcomes, cognition, and health-related quality of life (very low certainty of evidence). The panel felt that values and preferences, costs and resources, and equity favored the use of lower oxygenation targets. The ICM-RPG panel issued one conditional recommendation against the use of higher oxygenation targets: "We suggest against the routine use of higher oxygenation targets in adult ICU patients (conditional recommendation, very low certainty of evidence). Remark: an oxygenation target of SpO 2 88%-92% or PaO 2 8 kPa/60 mmHg is relevant and safe for most adult ICU patients.", (© 2023 Acta Anaesthesiologica Scandinavica Foundation.)

Importance: Considerable controversy exists regarding the best spontaneous breathing trial (SBT) technique to use., Objective: To summarize trials comparing alternative SBTs., Data Sources: Several databases (MEDLINE [from inception to February 2023], the Cochrane Central Register of Controlled Trials [in February 2023], and Embase [from inception to February 2023] and 5 conference proceedings (from January 1990 to April 2023) were searched in this systematic review and meta-analysis., Study Selection: Randomized trials directly comparing SBT techniques in critically ill adults or children and reporting at least 1 clinical outcome were selected., Data Extraction and Synthesis: Paired reviewers independently screened citations, abstracted data, and assessed quality for the systematic review and meta-analysis using Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA guidelines). Data were pooled using random-effects models., Main Outcomes and Measures: Primary outcomes included SBT success, extubation success, and reintubation., Results: The systematic review and meta-analysis identified 40 trials that included 6716 patients. Low-quality evidence (14 trials [n = 4459]) suggested that patients were not more likely to pass a pressure support (PS) compared with a T-piece SBT (risk ratio [RR], 1.04; 95% CI, 0.97-1.11; P = .31; I2 = 73%), unless 1 outlier trial accounting for all heterogeneity was excluded (RR, 1.09; 95% CI, 1.06-1.12; P < .001; I2 = 0% [13 trials; n = 3939]; moderate-quality evidence), but were significantly more likely to be successfully extubated (RR, 1.07; 95% CI, 1.04-1.10; P < .001; I2 = 0%; 16 trials [n = 4462]; moderate-quality evidence). Limited data (5 trials [n = 502]) revealed that patients who underwent automatic tube compensation/continuous positive airway pressure compared with PS SBTs had a significantly higher successful extubation rate (RR, 1.10; 95% CI, 1.00-1.21; P = .04; I2 = 0% [low-quality evidence]). Compared with T-piece SBTs, high-flow oxygen SBTs (3 trials [n = 386]) had significantly higher successful extubation (RR, 1.06; 95% CI, 1.00-1.11; P = .04; I2 = 0%) and lower reintubation (RR, 0.37; 95% CI, 0.21-0.65; P = <.001; I2 = 0% [both low-quality evidence]) rates. Credible subgroup effects were not found., Conclusions and Relevance: In this systematic review and meta-analysis, the findings suggest that patients undergoing PS compared with T-piece SBTs were more likely to be extubated successfully and more likely to pass an SBT, after exclusion of an outlier trial. Pressure support SBTs were not associated with increased risk of reintubation. Future trials should compare SBT techniques that maximize differences in inspiratory support.

Pulmonary embolism (PE) is a common and important medical emergency, encountered by clinicians across all acute care specialties. PE is a relatively uncommon cause of direct admission to the intensive care unit (ICU), but these patients are at high risk of death. More commonly, patients admitted to ICU develop PE as a complication of an unrelated acute illness. This paper reviews the epidemiology, diagnosis, risk stratification, and particularly the management of PE from a critical care perspective. Issues around prevention, anticoagulation, fibrinolysis, catheter-based techniques, surgical embolectomy, and extracorporeal support are discussed., (© 2023. Springer-Verlag GmbH Germany, part of Springer Nature.)

Background: Activation of a family member refers to their desire, knowledge, confidence, and skills that can inform engagement in healthcare. Family activation combined with opportunity can lead to engagement in care. No tool currently exists to measure family activation in acute care. Therefore, we aimed to develop and validate a tool to measure family activation in acute care., Methods: An interdisciplinary team of content experts developed the FAMily Activation Measure (FAM-Activate) through an iterative process. The FAM-Activate tool is a 4-item questionnaire with 5 Likert-type response options (ranging from strongly agree to strongly disagree). Scale scores are converted to a 0-100 point scoring range so that higher FAM-Activate scores indicate increased family activation. An overall FAM-Activate score (range 0-100) is calculated by adding the scores for each item and dividing by 4. We conducted reliability and predictive validity assessments to validate the instrument by administering the FAM-Activate tool to family members of patients in an acute cardiac unit at a tertiary care hospital. We obtained preliminary estimates of family engagement and satisfaction with care., Results: We surveyed 124 family participants (age 54.1±14.4; 73% women; 34% non-white). Participants were predominantly the adult child (38%) or spouse/partner (36%) of patients. The mean FAM-Activate score during hospitalization was 84.1±16.1. FAM-Activate had acceptable internal consistency (Cronbach's a = 0.74) and showed test-retest responsiveness. FAM-Activate was moderately correlated with engagement behavior (Pearson's correlation r = 0.47, P <0.0001). The FAM-Activate score was an independent predictor of family satisfaction, after adjusting for age, gender, relationship, and living status., Conclusion: The FAM-Activate tool was reliable and had predictive validity in the acute cardiac population. Further research is needed to explore whether improving family activation can lead to improved family engagement in care., Competing Interests: A member of the authorship group (MG) was involved in the developing the FAM-Activate measure., (Copyright: © 2024 Hallot et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.)

Objectives: The Berlin definition of acute respiratory distress syndrome (ARDS) was constructed for patients receiving invasive mechanical ventilation (IMV) with consideration given to issues related to reliability, feasibility, and validity. Notwithstanding, patients with acute respiratory failure (ARF) may be treated with high-flow nasal oxygen (HFNO) and may not fall within the scope of the original definition. We aimed to evaluate the predictive validity of the Berlin definition in HFNO-treated patients with COVID-19-related respiratory failure who otherwise met ARDS criteria., Design: Multicenter, prospective cohort study., Setting: Five ICUs of five centers in Argentina from March 2020 to September 2021., Patients: We consecutively included HFNO-treated patients older than 18 years with confirmed COVID-19-related ARF, a Pa o2 /F io2 of less than 300 mm Hg, bilateral infiltrates on imaging, and worsening respiratory symptoms for less than 1 week., Interventions: None., Measurements and Main Results: We evaluated the predictive validity of mortality at day 28 using the area under the receiver operating characteristics curve (AUC), compared the predictive validity across subgroups, and characterized relevant clinical outcomes. We screened 1,231 patients and included 696 ARDS patients [30 (4%) mild, 380 (55%) moderate, and 286 (41%) severe]. For the study cohort, the AUC for mortality at day 28 was 0.606 (95% CI, 0.561-0.651) with the AUC for subgroups being similar to that of the overall cohort. Two hundred fifty-six patients (37%) received IMV. By day 28, 142 patients (21%) had died, of whom 81 (57%) had severe ARDS. Mortality occurred primarily in patients who were transitioned to IMV., Conclusions: The predictive validity of the Berlin ARDS definition was similar for HFNO-treated patients as compared with the original population of invasively ventilated patients. Our findings support the extension of the Berlin definition to HFNO-treated patients with ARDS., Competing Interests: The authors have disclosed that they do not have any potential conflicts of interest., (Copyright © 2023 by the Society of Critical Care Medicine and Wolters Kluwer Health, Inc. All Rights Reserved.)

Objectives: To describe international variation in ethics and contract processes, identify predictors of approval times, and reasons for nonparticipation in an international observational study of ventilation discontinuation practices., Study Design and Setting: A nested cross-sectional survey of research personnel at 111 participating sites (representing 142 intensive care units [ICUs]) from six geographic regions (Canada, India, the United Kingdom, Europe, Australia/New Zealand, and the United States)., Results: We analyzed responses from 80 sites (72.1% response rate). A single local or central approval was required at 34/80 (42.5%) and 23/80 (28.75%), respectively. Of those requiring central ethics approval, 20/23 (87.0%) sites required an additional approval. Sites with central vs. other ethics approval processes had significantly longer times to ethics approval (176 vs. 42 days; P < 0.0001). The median time to contract execution was 140 days (range: 11-1,215) with sites in India and the United States having the shortest and longest times to contract execution, respectively. We did not identify independent predictors of approval times. Of 190 sites that initially agreed to participate, 78 (41%) sites (89 ICUs) were ultimately unable to participate., Conclusion: International ethics and contract approval times were lengthy and highly variable. Central ethics review processes significantly increased approval times., Competing Interests: Declaration of competing interest All authors affirm that they have no financial or nonfinancial conflicts of interest., (Copyright © 2023 Elsevier Inc. All rights reserved.)

Background: Current critical care pharmacist (CCP) practices and perceptions related to neuromuscular infusion (NMBI) use for acute respiratory distress syndrome (ARDS) maybe different with the COVID-19 pandemic and the publication of 2020 NMBI practice guidelines., Objective: To evaluate CCP practices and perceptions regarding NMBI use for patients with moderate-severe ARDS., Methods: We developed, tested, and electronically administered a questionnaire (7 parent-, 42 sub-questions) to 409 American College of Clinical Pharmacy (ACCP) Critical Care Practice and Research Network members in 12 geographically diverse states. The questionnaire focused on adults with moderate-severe ARDS (PaO 2 :FiO 2 <150) whose causes of dyssynchrony were addressed. Two reminders were sent at 10-day intervals., Results: Respondents [131/409 (32%)] primarily worked in a medical intensive care unit (ICU) 102 (78%). Compared to COVID-negative(-) ARDS patients, COVID positive(+) ARDS patients were twice as likely to receive a NMBI (34 ± 18 vs.16 ± 17%; P < 0.01). Respondents somewhat/strongly agreed a NMBI should be reserved until after trials of deep sedation (112, 86%) or proning (92, 81%) and that NMBI reduced barotrauma (88, 67%), dyssynchrony (87, 66%), and plateau pressure (79, 60%). Few respondents somewhat/strongly agreed that a NMBI should be initiated at ARDS onset (23, 18%) or that NMBI reduced 90-day mortality (12, 10%). Only 2/14 potential NMBI risks [paralysis awareness (101, 82%) and prolonged muscle weakness (84, 68%)] were frequently reported to be of high/very high concern. Multiple NMBI titration targets were assessed as very/extremely important including arterial pH (109, 88%), dyssynchrony (107, 86%), and PaO 2 : FiO 2 ratio (82, 66%). Train-of-four (55, 44%) and BIS monitoring (36, 29%) were deemed less important. Preferred NMBI discontinuation criteria included absence of dysschrony (84, 69%) and use ≥48 hour (72, 59%)., Conclusions and Relevance: Current critical care pharmacists believe NMBI for ARDS patients are best reserved until after trials of deep sedation or proning; unique considerations exist in COVID+ patients. Our results should be considered when ICU NMBI protocols are being developed and bedside decisions regarding NMBI use in ARDS are being formulated., Competing Interests: Declaration of Conflicting InterestsThe authors declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

Background: This update summarizes key changes made to the protocol for the Frequency of Screening and Spontaneous Breathing Trial (SBT) Technique Trial-North American Weaning Collaborative (FAST-NAWC) trial since the publication of the original protocol. This multicenter, factorial design randomized controlled trial with concealed allocation, will compare the effect of both screening frequency (once vs. at least twice daily) to identify candidates to undergo a SBT and SBT technique [pressure support + positive end-expiratory pressure vs. T-piece] on the time to successful extubation (primary outcome) in 760 critically ill adults who are invasively ventilated for at least 24 h in 20 North American intensive care units., Methods/design: Protocols for the pilot, factorial design trial and the full trial were previously published in J Clin Trials ( https://doi.org/10.4172/2167-0870.1000284 ) and Trials (https://doi: 10.1186/s13063-019-3641-8). As planned, participants enrolled in the FAST pilot trial will be included in the report of the full FAST-NAWC trial. In response to the onset of the coronavirus disease of 2019 (COVID-19) pandemic when approximately two thirds of enrollment was complete, we revised the protocol and consent form to include critically ill invasively ventilated patients with COVID-19. We also refined the statistical analysis plan (SAP) to reflect inclusion and reporting of participants with and without COVID-19. This update summarizes the changes made and their rationale and provides a refined SAP for the FAST-NAWC trial. These changes have been finalized before completion of trial follow-up and the commencement of data analysis., Trial Registration: Clinical Trials.gov NCT02399267., (© 2023. BioMed Central Ltd., part of Springer Nature.)

Purpose: The aim of this study was to characterize differences in directives to limit treatments and discontinue invasive mechanical ventilation (IMV) in elderly (65-80 years) and very elderly (> 80 years) intensive care unit (ICU) patients., Methods: We prospectively described new written orders to limit treatments, IMV discontinuation strategies [direct extubation, direct tracheostomy, spontaneous breathing trial (SBT), noninvasive ventilation (NIV) use], and associations between initial failed SBT and outcomes in 142 ICUs from 6 regions (Canada, India, United Kingdom, Europe, Australia/New Zealand, United States)., Results: We evaluated 788 (586 elderly; 202 very elderly) patients. Very elderly (vs. elderly) patients had similar withdrawal orders but significantly more withholding orders, especially cardiopulmonary resuscitation and dialysis, after ICU admission [67 (33.2%) vs. 128 (21.9%); p = 0.002]. Orders to withhold reintubation were written sooner in very elderly (vs. elderly) patients [4 (2-8) vs. 7 (4-13) days, p = 0.02]. Very elderly and elderly patients had similar rates of direct extubation [39 (19.3%) vs. 113 (19.3%)], direct tracheostomy [10 (5%) vs. 40 (6.8%)], initial SBT [105 (52%) vs. 302 (51.5%)] and initial successful SBT [84 (80%) vs. 245 (81.1%)]. Very elderly patients experienced similar ICU outcomes (mortality, length of stay, duration of ventilation) but higher hospital mortality [26 (12.9%) vs. 38 (6.5%)]. Direct tracheostomy and initial failed SBT were associated with worse outcomes. Regional differences existed in withholding orders at ICU admission and in withholding and withdrawal orders after ICU admission., Conclusions: Very elderly (vs. elderly) patients had more orders to withhold treatments after ICU admission and higher hospital mortality, but similar ICU outcomes and IMV discontinuation. Significant regional differences existed in withholding and withdrawal practices., (© 2023. Springer-Verlag GmbH Germany, part of Springer Nature.)

Background: Preconditioning deceased organ donors with calcineurin inhibitors (CNIs) may reduce ischemia-reperfusion injury to improve transplant outcomes., Methods: We searched MEDLINE, EMBASE, Cochrane Library, and conference proceedings for animal models of organ donation and transplantation, comparing donor treatment with CNIs with either placebo or no intervention, and evaluating outcomes for organ transplantation. Reviewers independently screened and selected studies, abstracted data, and assessed the risk of bias and clinical relevance of included studies. Where possible, we pooled results using meta-analysis; otherwise, we summarized findings descriptively., Results: Eighteen studies used various animals and a range of CNI agents and doses and evaluated their effects on a variety of transplant outcomes. The risk of bias and clinical applicability were poorly reported. Pooled analyses suggested benefit of CNI treatment on early graft function in renal transplants (3 studies; serum creatinine: ratio of means [RoM] 0.54; 95% confidence interval [CI], 0.34-0.86) but not for liver transplants (2 studies; serum alanine transaminase: RoM 0.61; 95% CI, 0.30-1.26; and serum aspartate aminotransferase: RoM 0.58; 95% CI, 0.26-1.31). We found no reduction in graft loss at 7 d (2 studies; risk ratio 0.54; 95% CI, 0.08-3.42). CNI treatment was associated with reduced transplant recipient levels of interleukin-6 (4 studies; RoM 0.36; 95% CI, 0.19-0.70), tumor necrosis factor-alpha (5 studies; RoM 0.36; 95% CI, 0.12-1.03), and cellular apoptosis (4 studies; RoM 0.30; 95% CI, 0.19-0.47)., Conclusions: Although this compendium of animal experiments suggests that donor preconditioning with CNIs may improve early kidney graft function, the limited ability to reproduce a true clinical environment in animal experiments and to assess for risk of bias in these experiments is a serious weakness that precludes current clinical application., (Copyright © 2023 The Author(s). Transplantation Direct. Published by Wolters Kluwer Health, Inc.)