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Background: Re-intubation secondary to post-extubation respiratory failure in post-operative patients is associated with increased patient morbidity and mortality. Non-invasive respiratory support (NRS) alternative to conventional oxygen therapy (COT), i.e., high-flow nasal oxygen, continuous positive airway pressure, and non-invasive ventilation (NIV), has been proposed to prevent or treat post-extubation respiratory failure. Aim of the present study is assessing the effects of NRS application, compared to COT, on the re-intubation rate (primary outcome), and time to re-intubation, incidence of nosocomial pneumonia, patient discomfort, intensive care unit (ICU) and hospital length of stay, and mortality (secondary outcomes) in adult patients extubated after surgery., Methods: A systematic review and network meta-analysis of randomized and non-randomized controlled trials. A search from Medline, Embase, Scopus, Cochrane Central Register of Controlled Trials, and Web of Science from inception until February 2, 2024 was performed., Results: Thirty-three studies (11,292 patients) were included. Among all NRS modalities, only NIV reduced the re-intubation rate, compared to COT (odds ratio 0.49, 95% confidence interval 0.28; 0.87, p = 0.015, I 2  = 60.5%, low certainty of evidence). In particular, this effect was observed in patients receiving NIV for treatment, while not for prevention, of post-extubation respiratory failure, and in patients at high, while not low, risk of post-extubation respiratory failure. NIV reduced the rate of nosocomial pneumonia, ICU length of stay, and ICU, hospital, and long-term mortality, while not worsening patient discomfort., Conclusions: In post-operative patients receiving NRS after extubation, NIV reduced the rate of re-intubation, compared to COT, when used for treatment of post-extubation respiratory failure and in patients at high risk of post-extubation respiratory failure., (© 2024. The Author(s).)

Background: In the last decades, noninvasive ventilation (NIV) has been increasingly used to support patients with hypercapnic and hypoxemic acute respiratory failure. Pressure ulcers are a frequently observed NIV-related adverse effect, directly related to interface type and exposure time. Switching to a different interface has been proposed as a solution to improve patient comfort. However, large studies investigating the benefit of this strategy are not available. Thus, the aim of the ROTAtional-USE of interface STUDY (ROTA-USE STUDY) is to investigate whether a protocolized rotational use of interfaces during NIV is effective in reducing the incidence of pressure ulcers., Methods: The ROTA-USE STUDY is a pragmatic, parallel arm, open-label, multicenter, spontaneous, non-profit, randomized controlled trial requiring non-significant risk medical devices, with the aim to determine whether a rotational strategy of NIV interfaces is associated with a lower incidence of pressure ulcers compared to the standard of care. In the intervention group, NIV mask will be randomly chosen and rotated every 6 h. In the control group, mask will be chosen according to the standard of care of the participating centers and changed in case of discomfort or in the presence of new pressure sores. In both groups, the skin underneath the mask will be inspected every 12 h for any possible damage by blinded assessors. The primary outcome is the proportion of patients developing new pressure sores at 36 h from randomization. The secondary outcomes are (i) onset of pressure sores measured at different time points, i.e., 12, 24, 36, 48, 60, 72, 84, and 96 h; (ii) number and stage of pressure sores and comfort measured at 12, 24, 36, 48, 60, 72, 84, and 96 h; and (iii) the economic impact of the protocolized rotational use of interfaces. A sample size of 239 subjects per group (intervention and control) is estimated to detect a 10% absolute difference in the proportion of patients developing pressure sores at 36 h., Discussion: The development of pressure ulcers is a common side effect of NIV that negatively affects the patients' comfort and tolerance, often leading to NIV failure and adverse outcomes. The ROTA-USE STUDY will determine whether a protocolized rotational approach can reduce the incidence, number, and severity of pressure ulcers in NIV-treated patients., Trial Registration: ClinicalTrials.gov NCT05513508. Registered on August 24, 2022., (© 2023. BioMed Central Ltd., part of Springer Nature.)

Background: The effect of noninvasive respiratory support (NRS), including high-flow nasal oxygen, bi-level positive airway pressure and continuous positive airway pressure (noninvasive ventilation (NIV)), for preventing and treating post-extubation respiratory failure is still unclear. Our objective was to assess the effects of NRS on post-extubation respiratory failure, defined as re-intubation secondary to post-extubation respiratory failure (primary outcome). Secondary outcomes included the incidence of ventilator-associated pneumonia (VAP), discomfort, intensive care unit (ICU) and hospital mortality, ICU and hospital length of stay (LOS), and time to re-intubation. Subgroup analyses considered "prophylactic" versus "therapeutic" NRS application and subpopulations (high-risk, low-risk, post-surgical and hypoxaemic patients)., Methods: We undertook a systematic review and network meta-analysis (Research Registry: reviewregistry1435). PubMed, Embase, CENTRAL, Scopus and Web of Science were searched (from inception until 22 June 2022). Randomised controlled trials (RCTs) investigating the use of NRS after extubation in ICU adult patients were included., Results: 32 RCTs entered the quantitative analysis (5063 patients). Compared with conventional oxygen therapy, NRS overall reduced re-intubations and VAP (moderate certainty). NIV decreased hospital mortality (moderate certainty), and hospital and ICU LOS (low and very low certainty, respectively), and increased discomfort (moderate certainty). Prophylactic NRS did not prevent extubation failure in low-risk or hypoxaemic patients., Conclusion: Prophylactic NRS may reduce the rate of post-extubation respiratory failure in ICU patients., Competing Interests: Conflict of interest: None related to the present work. P. Navalesi's research lab has received grants/research equipment from Draeger, Intersurgical SPA and Gilead. P. Navalesi receives royalties from Intersurgical SPA for the Helmet Next invention. He has also received speaking fees from Getinge, Intersurgical SPA, Mindray, Gilead, MSD, Draeger and Medicair. The other authors have no other competing interests to declare., (Copyright ©The authors 2023.)

Rationale: When compared with VenturiMask after extubation, high-flow nasal oxygen provides physiological advantages. Objectives: To establish whether high-flow oxygen prevents endotracheal reintubation in hypoxemic patients after extubation, compared with VenturiMask. Methods: In this multicenter randomized trial, 494 patients exhibiting Pa O 2 :Fi O 2 ratio ⩽ 300 mm Hg after extubation were randomly assigned to receive high-flow or VenturiMask oxygen, with the possibility to apply rescue noninvasive ventilation before reintubation. High-flow use in the VenturiMask group was not permitted. Measurements and Main Results: The primary outcome was the rate of reintubation within 72 hours according to predefined criteria, which were validated a posteriori by an independent adjudication committee. Main secondary outcomes included reintubation rate at 28 days and the need for rescue noninvasive ventilation according to predefined criteria. After intubation criteria validation ( n  = 492 patients), 32 patients (13%) in the high-flow group and 27 patients (11%) in the VenturiMask group required reintubation at 72 hours (unadjusted odds ratio, 1.26 [95% confidence interval (CI), 0.70-2.26]; P  = 0.49). At 28 days, the rate of reintubation was 21% in the high-flow group and 23% in the VenturiMask group (adjusted hazard ratio, 0.89 [95% CI, 0.60-1.31]; P  = 0.55). The need for rescue noninvasive ventilation was significantly lower in the high-flow group than in the VenturiMask group: at 72 hours, 8% versus 17% (adjusted hazard ratio, 0.39 [95% CI, 0.22-0.71]; P  = 0.002) and at 28 days, 12% versus 21% (adjusted hazard ratio, 0.52 [95% CI, 0.32-0.83]; P  = 0.007). Conclusions: Reintubation rate did not significantly differ between patients treated with VenturiMask or high-flow oxygen after extubation. High-flow oxygen yielded less frequent use of rescue noninvasive ventilation. Clinical trial registered with www.clinicaltrials.gov (NCT02107183).

Background: High-flow nasal cannula (HFNC) has become a frequently used noninvasive form of respiratory support in acute settings; however, evidence supporting its use has only recently emerged. These guidelines provide evidence-based recommendations for the use of HFNC alongside other noninvasive forms of respiratory support in adults with acute respiratory failure (ARF)., Materials and Methodology: The European Respiratory Society task force panel included expert clinicians and methodologists in pulmonology and intensive care medicine. The task force used the GRADE (Grading of Recommendations, Assessment, Development and Evaluation) methods to summarise evidence and develop clinical recommendations for the use of HFNC alongside conventional oxygen therapy (COT) and noninvasive ventilation (NIV) for the management of adults in acute settings with ARF., Results: The task force developed eight conditional recommendations, suggesting the use of 1) HFNC over COT in hypoxaemic ARF; 2) HFNC over NIV in hypoxaemic ARF; 3) HFNC over COT during breaks from NIV; 4) either HFNC or COT in post-operative patients at low risk of pulmonary complications; 5) either HFNC or NIV in post-operative patients at high risk of pulmonary complications; 6) HFNC over COT in nonsurgical patients at low risk of extubation failure; 7) NIV over HFNC for patients at high risk of extubation failure unless there are relative or absolute contraindications to NIV; and 8) trialling NIV prior to use of HFNC in patients with COPD and hypercapnic ARF., Conclusions: HFNC is a valuable intervention in adults with ARF. These conditional recommendations can assist clinicians in choosing the most appropriate form of noninvasive respiratory support to provide to patients in different acute settings., Competing Interests: Conflict of interest: S. Oczkowski reports support for the current manuscript from librarian support services; support for attending meetings and/or travel from ERS, European Society of Intensive Care Medicine and Society of Critical Care Medicine, outside the submitted work. Conflict of interest: B. Ergan has nothing to disclose. Conflict of interest: L. Bos reports grants from the Dutch Lung Foundation (young investigator grant), the Dutch Lung Foundation and Health Holland (public-private partnership grant), the Dutch Lung Foundation (Dirkje Postma Award), IMI COVID19 initiative and Amsterdam UMC fellowship, outside the submitted work. Conflict of interest: M. Chatwin reports lecture fees from ResMed UK, Breas Medical UK, MPR Italy; and since December 2020 has worked part time for Breas Medical as their global clinical specialist, including CAB membership and support for attending meetings and/or travel. Conflict of interest: M. Ferrer has nothing to disclose. Conflict of interest: C. Gregoretti reports consulting fees from Mindray and Air Liquide; lecture fees from Vivisol, Philips and Air Liquide; support for attending meetings and/or travel from Fisher & Paykel; outside the submitted work. Conflict of interest: L. Heunks reports grants from InflaRx; consulting fees from Liberate Medical, USA; speaker fees from Fisher & Paykel and Maquet; outside the submitted work. Conflict of interest: J-P. Frat reports funding, provision of study materials, personal fees for lectures, travels and accommodations expenses reimbursement from Fisher and Paykel Healthcare; personal fees as a member of a scientific board from SOS Oxygene; grants from French Ministry of health; outside the submitted work. Conflict of interest: F. Longhini reports honoraria for a lecture from Draeger; issued patent for a new device for noninvasive ventilation (European patent number 3320941) from Intersurgical SPA; outside the submitted work. Conflict of interest: S. Nava has nothing to disclose. Conflict of interest: P. Navalesi has nothing to disclose. Conflict of interest: A. Ozsancak Uğurlu has nothing to disclose. Conflict of interest: L. Pisani has nothing to disclose. Conflict of interest: T. Renda has nothing to disclose. Conflict of interest: A.W. Thille reports payments for lectures and support for attending meetings and/or travel from Fisher & Paykel; Fisher & Paykel provided the high-flow nasal oxygen equipment and masks for NIV in several randomised clinical trials coordinated by our center. Conflict of interest: J.C. Winck reports webinar fees from Armstrong Medical, Breas, Philips and Nippon Gases; outside the submitted work. Conflict of interest: W. Windisch reports grants from Philips/Respironics/USA, Löwenstein Medical/Germany, VitalAire/Germany and Vivisol/Germany; speaking fees from Philips/Respironics/USA, Löwenstein Medical/Germany and VitalAire/Germany; outside the submitted work. Conflict of interest: T. Tonia acts as ERS Methodologist. Conflict of interest: J. Boyd is an employee of the European Lung Foundation. Conflict of interest: G. Sotgiu has nothing to disclose. Conflict of interest: R. Scala has nothing to disclose., (Copyright ©The authors 2022. 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The efficacy of non-invasive ventilation (NIV) in acute respiratory failure secondary to SARS-CoV-2 infection remains controversial. Current literature mainly examined efficacy, safety and potential predictors of NIV failure provided out of the intensive care unit (ICU). On the contrary, the outcomes of ICU patients, intubated after NIV failure, remain to be explored. The aims of the present study are: (1) investigating in-hospital mortality in coronavirus disease 2019 (COVID-19) ICU patients receiving endotracheal intubation after NIV failure and (2) assessing whether the length of NIV application affects patient survival. This observational multicenter study included all consecutive COVID-19 adult patients, admitted into the twenty-five ICUs of the COVID-19 VENETO ICU network (February-April 2020), who underwent endotracheal intubation after NIV failure. Among the 704 patients admitted to ICU during the study period, 280 (40%) presented the inclusion criteria and were enrolled. The median age was 69 [60-76] years; 219 patients (78%) were male. In-hospital mortality was 43%. Only the length of NIV application before ICU admission (OR 2.03 (95% CI 1.06-4.98), p = 0.03) and age (OR 1.18 (95% CI 1.04-1.33), p < 0.01) were identified as independent risk factors of in-hospital mortality; whilst the length of NIV after ICU admission did not affect patient outcome. In-hospital mortality of ICU patients intubated after NIV failure was 43%. Days on NIV before ICU admission and age were assessed to be potential risk factors of greater in-hospital mortality., (© 2021. The Author(s).)

Background: Awake prone position is an emerging rescue therapy applied in patients undergoing noninvasive ventilation (NIV) for acute hypoxemic respiratory failure (ARF) related to novel coronavirus disease (COVID-19). Although applied to stabilize respiratory status, in awake patients, the application of prone position may reduce comfort with a consequent increase in the workload imposed on respiratory muscles. Thus, we primarily ascertained the effect of awake prone position on diaphragmatic thickening fraction, assessed through ultrasound, in COVID-19 patients undergoing NIV., Methods: We enrolled all COVID-19 adult critically ill patients, admitted to intensive care unit (ICU) for hypoxemic ARF and undergoing NIV, deserving of awake prone positioning as a rescue therapy. Exclusion criteria were pregnancy and any contraindication to awake prone position and NIV. On ICU admission, after NIV onset, in supine position, and at 1 h following awake prone position application, diaphragmatic thickening fraction was obtained on the right side. Across all the study phases, NIV was maintained with the same setting present at study entry. Vital signs were monitored throughout the entire study period. Comfort was assessed through numerical rating scale (0 the worst comfort and 10 the highest comfort level). Data were presented in median and 25th-75th percentile range., Results: From February to May 2021, 20 patients were enrolled and finally analyzed. Despite peripheral oxygen saturation improvement [96 (94-97)% supine vs 98 (96-99)% prone, p = 0.008], turning to prone position induced a worsening in comfort score from 7.0 (6.0-8.0) to 6.0 (5.0-7.0) (p = 0.012) and an increase in diaphragmatic thickening fraction from 33.3 (25.7-40.5)% to 41.5 (29.8-50.0)% (p = 0.025)., Conclusions: In our COVID-19 patients assisted by NIV in ICU, the application of awake prone position improved the oxygenation at the expense of a greater diaphragmatic thickening fraction compared to supine position. Trial registration ClinicalTrials.gov, number NCT04904731. Registered on 05/25/2021, retrospectively registered. https://clinicaltrials.gov/ct2/show/NCT04904731 ., (© 2021. The Author(s).)

Background: Noninvasive respiratory support (NIRS) has been diffusely employed outside the intensive care unit (ICU) to face the high request of ventilatory support due to the massive influx of patients with acute respiratory failure (ARF) caused by coronavirus-19 disease (COVID-19). We sought to summarize the evidence on clinically relevant outcomes in COVID-19 patients supported by NIV outside the ICU., Methods: We searched PUBMED®, EMBASE®, and the Cochrane Controlled Clinical trials register, along with medRxiv and bioRxiv repositories for pre-prints, for observational studies and randomized controlled trials, from inception to the end of February 2021. Two authors independently selected the investigations according to the following criteria: (1) observational study or randomized clinical trials enrolling ≥ 50 hospitalized patients undergoing NIRS outside the ICU, (2) laboratory-confirmed COVID-19, and (3) at least the intra-hospital mortality reported. Preferred Reporting Items for Systematic reviews and Meta-analysis guidelines were followed. Data extraction was independently performed by two authors to assess: investigation features, demographics and clinical characteristics, treatments employed, NIRS regulations, and clinical outcomes. Methodological index for nonrandomized studies tool was applied to determine the quality of the enrolled studies. The primary outcome was to assess the overall intra-hospital mortality of patients under NIRS outside the ICU. The secondary outcomes included the proportions intra-hospital mortalities of patients who underwent invasive mechanical ventilation following NIRS failure and of those with 'do-not-intubate' (DNI) orders., Results: Seventeen investigations (14 peer-reviewed and 3 pre-prints) were included with a low risk of bias and a high heterogeneity, for a total of 3377 patients. The overall intra-hospital mortality of patients receiving NIRS outside the ICU was 36% [30-41%]. 26% [21-30%] of the patients failed NIRS and required intubation, with an intra-hospital mortality rising to 45% [36-54%]. 23% [15-32%] of the patients received DNI orders with an intra-hospital mortality of 72% [65-78%]. Oxygenation on admission was the main source of between-study heterogeneity., Conclusions: During COVID-19 outbreak, delivering NIRS outside the ICU revealed as a feasible strategy to cope with the massive demand of ventilatory assistance., Registration: PROSPERO, https://www.crd.york.ac.uk/prospero/ , CRD42020224788, December 11, 2020., (© 2021. The Author(s).)

In patients intubated for hypoxemic acute respiratory failure (ARF) related to novel coronavirus disease (COVID-19), we retrospectively compared two weaning strategies, early extubation with immediate non-invasive ventilation (NIV) versus standard weaning encompassing spontaneous breathing trial (SBT), with respect to IMV duration (primary endpoint), extubation failures and reintubations, rate of tracheostomy, intensive care unit (ICU) length of stay and mortality (additional endpoints). All COVID-19 adult patients, intubated for hypoxemic ARF and subsequently extubated, were enrolled. Patients were included in two groups, early extubation followed by immediate NIV application, and conventionally weaning after passing SBT. 121 patients were enrolled and analyzed, 66 early extubated and 55 conventionally weaned after passing an SBT. IMV duration was 9 [6-11] days in early extubated patients versus 11 [6-15] days in standard weaning group (p = 0.034). Extubation failures [12 (18.2%) vs. 25 (45.5%), p = 0.002] and reintubations [12 (18.2%) vs. 22 (40.0%) p = 0.009] were fewer in early extubation compared to the standard weaning groups, respectively. Rate of tracheostomy, ICU mortality, and ICU length of stay were no different between groups. Compared to standard weaning, early extubation followed by immediate NIV shortened IMV duration and reduced the rate of extubation failure and reintubation.

Background: Usefulness of noninvasive ventilation (NIV) in weaning patients with non-hypercapnic hypoxemic acute respiratory failure (hARF) is unclear. The study aims to assess in patients with non-hypercapnic hARF, the efficacy of NIV after early extubation, compared to standard weaning., Methods: In this individual patient data meta-analysis, we searched EMBASE, Medline and Cochrane Central Register of Controlled Trials to identify potentially eligible randomized controlled trials published from database inception to October 2020. To be eligible, studies had to include patients treated with NIV after early extubation and compared to conventional weaning in adult non-hypercapnic hARF patients. Anonymized individual patient data from eligible studies were provided by study investigators. Using one-step and two-step meta-analysis models we tested the difference in total days spent on invasive ventilation., Results: We screened 1605 records. Six studies were included in quantitative synthesis. Overall, 459 participants (mean [SD] age, 62 [15] years; 269 [59%] males) recovering from hARF were included in the analysis (233 in the intervention group and 226 controls). Participants receiving NIV had a shorter duration of invasive mechanical ventilation compared to control group (mean difference, - 3.43; 95% CI - 5.17 to - 1.69 days, p < 0.001), a shorter duration of total days spent on mechanical ventilation (mean difference, - 2.04; 95% CI - 3.82 to - 0.27 days, p = 0.024), a reduced risk of ventilatory associated pneumonia (odds ratio, 0.24; 95% CI 0.08 to 0.71, p = 0.014), a reduction of time spent in ICU (time ratio, 0.81; 95% CI 0.68 to 0.96, p = 0.015) and in-hospital (time ratio, 0.81; 95% CI 0.69 to 0.95, p = 0.010), with no difference in ICU mortality., Conclusions: Although primary studies are limited, using an individual patient data metanalysis approach, NIV after early extubation appears useful in reducing total days spent on invasive mechanical ventilation., Trial Registration: The protocol was registered to PROSPERO database on 12/06/2019 and available at PROSPERO website inserting the study code i.e., CRD42019133837.

Background: The efficacy and safety of high flow nasal therapy (HFNT) in patients with acute hypercapnic exacerbation of chronic obstructive pulmonary disease (AECOPD) are unclear. Our aim was to evaluate the short-term effect of HFNT versus NIV in patients with mild-to-moderate AECOPD, with the hypothesis that HFNT is non-inferior to NIV on CO 2 clearance after 2 h of treatment., Methods: We performed a multicenter, non-inferiority randomized trial comparing HFNT and noninvasive ventilation (NIV) in nine centers in Italy. Patients were eligible if presented with mild-to-moderate AECOPD (arterial pH 7.25-7.35, PaCO 2  ≥ 55 mmHg before ventilator support). Primary endpoint was the mean difference of PaCO 2 from baseline to 2 h (non-inferiority margin 10 mmHg) in the per-protocol analysis. Main secondary endpoints were non-inferiority of HFNT to NIV in reducing PaCO 2 at 6 h in the per-protocol and intention-to-treat analysis and rate of treatment changes., Results: Seventy-nine patients were analyzed (80 patients randomized). Mean differences for PaCO 2 reduction from baseline to 2 h were - 6.8 mmHg (± 8.7) in the HFNT and - 9.5 mmHg (± 8.5) in the NIV group (p = 0.404). By 6 h, 32% of patients (13 out of 40) in the HFNT group switched to NIV and one to invasive ventilation. HFNT was statistically non-inferior to NIV since the 95% confidence interval (CI) upper boundary of absolute difference in mean PaCO 2 reduction did not reach the non-inferiority margin of 10 mmHg (absolute difference 2.7 mmHg; 1-sided 95% CI 6.1; p = 0.0003). Both treatments had a significant effect on PaCO 2 reductions over time, and trends were similar between groups. Similar results were found in both per-protocol at 6 h and intention-to-treat analysis., Conclusions: HFNT was statistically non-inferior to NIV as initial ventilatory support in decreasing PaCO 2 after 2 h of treatment in patients with mild-to-moderate AECOPD, considering a non-inferiority margin of 10 mmHg. However, 32% of patients receiving HFNT required NIV by 6 h. Further trials with superiority design should evaluate efficacy toward stronger patient-related outcomes and safety of HFNT in AECOPD., Trial Registration: The study was prospectively registered on December 12, 2017, in ClinicalTrials.gov (NCT03370666).

Background: Early identification of noninvasive ventilation (NIV) outcome predictors in patients with COPD who are experiencing acute hypercapnic respiratory failure consequent to exacerbation or pneumonia is a critical issue. The primary aim of this study was to investigate the feasibility of performing diaphragmatic ultrasound for excursion, thickness, and thickening fraction in highly dyspneic subjects with COPD admitted to the emergency department for exacerbation or pneumonia, before starting NIV (T0) and after the first (T1) and second hour (T2) of treatment. Secondarily, we determined whether these variables predicted early NIV failure., Methods: Adult subjects with COPD admitted to the emergency department for exacerbation or pneumonia requiring NIV were eligible. Right-sided diaphragmatic excursion, bilateral thickness, thickening fraction, and arterial blood gas analyses were performed at T0, T1, and T2. Feasibility was estimated by considering the number of subjects whose diaphragmatic function could be evaluated at each time point. At T2, subjects were classified in 2 subgroups according to early NIV failure, which was defined as the inability to achieve a pH ≥ 7.35; the ability to achieve pH ≥ 7.35 indicated NIV success., Results: Of the 22 subjects enrolled, 21 underwent complete diaphragm ultrasound evaluation (ie, right excursion and bilateral thickness at T0, T1, and T2) for a total of 63 excursion and 126 thickness assessments. At T2, 12 NIV successes and 9 NIV failures were recorded. Diaphragmatic excursion was greater in NIV successes than in NIV failures at T0 (1.92 [1.22-2.54] cm versus 1.00 [0.60-1.41] cm, P = .02), at T1 (2.14 [1.76-2.77] cm versus 0.93 [0.82-1.27] cm, P = .007), and at T2 (1.99 [1.63-2.54] cm versus 1.20 [0.79-1.41] cm, P = .008), respectively. Diaphragmatic thickness and thickening fraction were similar in both groups., Conclusions: In our emergency department setting, diaphragm ultrasound was a feasible and reliable tool to monitor highly dyspneic acute hypercapnic respiratory failure subjects with COPD undergoing NIV. (ClinicalTrials.gov registration NCT03314883.)., Competing Interests: The authors have disclosed no conflicts of interest., (Copyright © 2019 by Daedalus Enterprises.)

We performed a bench (BS) and human (HS) study to test the hypothesis that estimation of tidal volume (V T ) during noninvasive helmet pressure support ventilation (nHPSV) would be possible using a turbine driven ventilator (TDV) coupled with an intentional leak single-limb vented circuit. During the BS a mannequin was connected to a lung simulator (LS) and at different conditions of respiratory mechanics, positive end expiratory pressure (PEEP) levels and leaks (30, 50 and 80 L/min). All differences were within the 95% limits of agreement (LoA) in all conditions in the Bland-Altman plot. The overall bias (difference between V T measured by TDV and LS) was 35 ml (95% LoA 10 to 57 ml), 15 ml (95% LoA -40 to 70 ml), 141 ml (95% LoA 109 to 173 ml) in the normal, restrictive and obstructive conditions. The bias at different leaks flow in normal condition was 29 ml (95% LoA 19 to 38 ml). In the HS four healthy volunteers using nHPSV had a pneumotachograph (P) inserted through a mouthpiece to measure subject's V T .The bias showed a scarce clinical relevance. In conclusions, V T estimation seems to be feasible and accurate in all conditions but the obstructive one. Additional leaks seem not to affect V T reliability.

Background: Noninvasive ventilation (NIV) is indicated to treat respiratory acidosis due to exacerbation of chronic obstructive pulmonary disease (COPD). Recent nonrandomized studies also demonstrated some physiological effects of high-flow nasal therapy (HFNT) in COPD patients. We designed a prospective, unblinded, multicenter, randomized controlled trial to assess the noninferiority of HFNT compared to NIV with respect to the reduction of arterial partial pressure of carbon dioxide (PaCO 2 ) in patients with hypercapnic acute respiratory failure with mild-to-moderate respiratory acidosis., Methods: We will enroll adult patients with acute hypercapnic respiratory failure, as defined by arterial pH between 7.25 and 7.35 and PaCO 2  ≥ 55 mmHg. Patients will be randomly assigned 1:1 to receive NIV or HFNT. NIV will be applied through a mask with a dedicated ventilator in pressure support mode. Positive end-expiratory pressure will be set at 3-5 cmH 2 O with inspiratory support to obtain a tidal volume between 6 and 8 ml/kg of ideal body weight. HFNT will be initially set at a temperature of 37 °C and a flow of 60 L/min. At 2 and 6 h we will assess arterial blood gases, vital parameters, respiratory rate, treatment intolerance and failure, need for endotracheal intubation, time spent under mechanical ventilation (both invasive and NIV), intensive care unit and hospital length of stay, and hospital mortality. Based on an α error of 5% and a β error of 80%, with a standard deviation for PaCO 2 equal to 15 mmHg and a noninferiority limit of 10 mmHg, we computed a sample size of 56 patients. Considering potential drop-outs and nonparametric analysis, the final computed sample size was 80 patients (40 per group)., Discussion: HFNT is more comfortable than NIV in COPD patients recovering from an episode of exacerbation. If HFNT would not be inferior to NIV, HFNT could be considered as an alternative to NIV to treat COPD patients with mild-to-moderate respiratory acidosis., Trial Registration: ClinicalTrials.gov, NCT03370666 . Registered on December 12, 2017.

Background: In patients with COPD exacerbation, noninvasive ventilation (NIV) is strongly recommended. NIV is generally delivered by using patient triggered and flow-cycled pressure support through a face mask. A specific method to generate neurally-controlled pressure support has been shown to improve comfort and patient-ventilator interaction. In addition, the helmet interface was better tolerated by patients compared with a face mask. Herein, we compared neurally-controlled pressure support through a helmet with pressure support through a face mask with respect to subject comfort, breathing pattern, gas exchange, pressurization and triggering performance, and patient-ventilator synchrony., Methods: Two 30-min trials of NIV were randomly delivered to 10 subjects with COPD exacerbation redundant: (1) pressure support through a face mask with inspiratory pressure support of ≥8 cm H 2 O to obtain a tidal volume of 6-8 mL/kg of ideal body weight; and (2) NAVA through a helmet, setting the neurally-adjusted ventilatory assist level at 15 cm H 2 O/μV, with an upper airway pressure limit to obtain the same overall airway pressure applied during pressure support through a face mask. We assessed subject comfort, breathing frequency, respiratory drive, arterial blood gases, pressure-time product (PTP) of the first 300 ms and 500ms after initiation of subject effort, inspiratory trigger delay, and rate of asynchrony determined as the asynchrony index., Results: Median and interquartile range NAVA through a helmet improved comfort (7.0 [6.0-8.0]) compared with pressure support through a face mask (5.0 [4.7-5.2], P = .005). The breathing pattern was not different between the methods. Respiratory drive was slightly, although not significantly, reduced ( P = .19) during NAVA through a helmet in comparison with pressure support through a face mask. Gas exchange was also not different between the trials. The PTP of the first 300 ms ( P = .92) and PTP of the first 500 ms ( P = .08) were not statistically different between trials, whereas triggering performance, patient-ventilator interaction, and synchrony were all improved by NAVA through a helmet compared with pressure support through a face mask., Conclusions: In the subjects with COPD with exacerbation, NAVA through a helmet improved comfort, triggering performance, and patient-ventilator synchrony compared with pressure support through a face mask., (Copyright © 2019 by Daedalus Enterprises.)

Background: High-Flow through Nasal Cannula (HFNC) is a system delivering heated humidified air-oxygen mixture at a flow up to 60 L/min. Despite increasing evidence in hypoxemic acute respiratory failure, a few is currently known in chronic obstructive pulmonary disease (COPD) patients., Objective: To describe the rationale and physiologic advantages of HFNC in COPD patients, and to systematically review the literature on the use of HFNC in stable and exacerbated COPD patients, separately., Methods: A search strategy was launched on MEDLINE. Two authors separately screened all potential references. All (randomized, non-randomized and quasi-randomized) trials dealing with the use of HFNC in both stable and exacerbated COPD patients in MEDLINE have been included in the review., Results: Twenty-six studies have been included. HFNC: 1) provides heated and humidified airoxygen admixture; 2) washes out the anatomical dead space of the upper airway; 3) generates a small positive end-expiratory pressure; 4) guarantees a more stable inspired oxygen fraction, as compared to conventional oxygen therapy (COT); and 5) is more comfortable as compared to both COT and non-invasive ventilation (NIV). In stable COPD patients, HFNC improves gas exchange, the quality of life and dyspnea with a reduced cost of muscle energy expenditure, compared to COT. In exacerbated COPD patients, HFNC may be an alternative to NIV (in case of intolerance) and to COT at extubation or NIV withdrawal., Conclusion: Though evidence of superiority still lacks and further studies are necessary, HFNC might play a role in the treatment of both stable and exacerbated COPD patients., (Copyright© Bentham Science Publishers; For any queries, please email at epub@benthamscience.net.)

Purpose: Noninvasive ventilation (NIV) may facilitate withdrawal of invasive mechanical ventilation (i-MV) and shorten intensive care unit (ICU) length of stay (LOS) in hypercapnic patients, while data are lacking on hypoxemic patients. We aim to determine whether NIV after early extubation reduces the duration of i-MV and ICU LOS in patients recovering from hypoxemic acute respiratory failure., Methods: Highly selected non-hypercapnic hypoxemic patients were randomly assigned to receive NIV after early or standard extubation. Co-primary end points were duration of i-MV and ICU LOS. Secondary end points were treatment failure, severe events (hemorrhagic, septic, cardiac, renal or neurologic episodes, pneumothorax or pulmonary embolism), ventilator-associated pneumonia (VAP) or tracheobronchitis (VAT), tracheotomy, percent of patients receiving sedation after study enrollment, hospital LOS, and ICU and hospital mortality., Results: We enrolled 130 consecutive patients, 65 treatments and 65 controls. Duration of i-MV was shorter in the treatment group than for controls [4.0 (3.0-7.0) vs. 5.5 (4.0-9.0) days, respectively, p = 0.004], while ICU LOS was not significantly different [8.0 (6.0-12.0) vs. 9.0 (6.5-12.5) days, respectively (p = 0.259)]. Incidence of VAT or VAP (9% vs. 25%, p = 0.019), rate of patients requiring infusion of sedatives after enrollment (57% vs. 85%, p = 0.001), and hospital LOS, 20 (13-32) vs. 27(18-39) days (p = 0.043) were all significantly reduced in the treatment group compared with controls. There were no significant differences in ICU and hospital mortality or in the number of treatment failures, severe events, and tracheostomies., Conclusions: In highly selected hypoxemic patients, early extubation followed by immediate NIV application reduced the days spent on invasive ventilation without affecting ICU LOS.

Background: Noninvasive ventilation is used worldwide in many settings. Its effectiveness has been proven for common clinical conditions in critical care such as cardiogenic pulmonary edema and chronic obstructive pulmonary disease exacerbations. Since the first pioneering studies of noninvasive ventilation in critical care in the late 1980s, thousands of studies and articles have been published on this topic. Interestingly, some aspects remain controversial (e.g. its use in de-novo hypoxemic respiratory failure, role of sedation, self-induced lung injury). Moreover, the role of NIV has recently been questioned and reconsidered in light of the recent reports of new techniques such as high-flow oxygen nasal therapy., Methods: We conducted a survey among leading experts on NIV aiming to 1) identify a selection of 10 important articles on NIV in the critical care setting 2) summarize the reasons for the selection of each study 3) offer insights on the future for both clinical application and research on NIV., Results: The experts selected articles over a span of 26 years, more clustered in the last 15 years. The most voted article studied the role of NIV in acute exacerbation chronic pulmonary disease. Concerning the future of clinical applications for and research on NIV, most of the experts forecast the development of innovative new interfaces more adaptable to patients characteristics, the need for good well-designed large randomized controlled trials of NIV in acute "de novo" hypoxemic respiratory failure (including its comparison with high-flow oxygen nasal therapy) and the development of software-based NIV settings to enhance patient-ventilator synchrony., Conclusions: The selection made by the experts suggests that some applications of NIV in critical care are supported by solid data (e.g. COPD exacerbation) while others are still waiting for confirmation. Moreover, the identified insights for the future would lead to improved clinical effectiveness, new comparisons and evaluation of its role in still "lack of full evidence" clinical settings.

Noninvasive mechanical ventilation (NIV) is widely used in the acute care setting for acute respiratory failure (ARF) across a variety of aetiologies. This document provides European Respiratory Society/American Thoracic Society recommendations for the clinical application of NIV based on the most current literature.The guideline committee was composed of clinicians, methodologists and experts in the field of NIV. The committee developed recommendations based on the GRADE (Grading, Recommendation, Assessment, Development and Evaluation) methodology for each actionable question. The GRADE Evidence to Decision framework in the guideline development tool was used to generate recommendations. A number of topics were addressed using technical summaries without recommendations and these are discussed in the supplementary material.This guideline committee developed recommendations for 11 actionable questions in a PICO (population-intervention-comparison-outcome) format, all addressing the use of NIV for various aetiologies of ARF. The specific conditions where recommendations were made include exacerbation of chronic obstructive pulmonary disease, cardiogenic pulmonary oedema, de novo hypoxaemic respiratory failure, immunocompromised patients, chest trauma, palliation, post-operative care, weaning and post-extubation.This document summarises the current state of knowledge regarding the role of NIV in ARF. Evidence-based recommendations provide guidance to relevant stakeholders., Competing Interests: Conflict of interest: Disclosures can be found alongside this article at erj.ersjournals.com, (Copyright ©ERS 2017.)

Background: Noninvasive ventilation (NIV) is generally delivered using pneumatically-triggered and cycled-off pressure support (PS P ) through a mask. Neurally adjusted ventilatory assist (NAVA) is the only ventilatory mode that uses a non-pneumatic signal, i.e., diaphragm electrical activity (EAdi), to trigger and drive ventilator assistance. A specific setting to generate neurally controlled pressure support (PS N ) was recently proposed for delivering NIV by helmet. We compared PS N with PS P and NAVA during NIV using a facial mask, with respect to patient comfort, gas exchange, and patient-ventilator interaction and synchrony., Methods: Three 30-minute trials of NIV were randomly delivered to 14 patients immediately after extubation to prevent post-extubation respiratory failure: (1) PS P , with an inspiratory support ≥8 cmH 2 O; (2) NAVA, adjusting the NAVA level to achieve a comparable peak EAdi (EAdi peak ) as during PS P ; and (3) PS N , setting the NAVA level at 15 cmH 2 O/μV with an upper airway pressure (Paw) limit to obtain the same overall Paw applied during PS P . We assessed patient comfort, peak inspiratory flow (PIF), time to reach PIF (PIF time ), EAdi peak , arterial blood gases, pressure-time product of the first 300 ms (PTP 300-index ) and 500 ms (PTP 500-index ) after initiation of patient effort, inspiratory trigger delay (Delay TR-insp ), and rate of asynchrony, determined as asynchrony index (AI%). The categorical variables were compared using the McNemar test, and continuous variables by the Friedman test followed by the Wilcoxon test with Bonferroni correction for multiple comparisons (p < 0.017)., Results: PS N significantly improved patient comfort, compared to both PS P (p = 0.001) and NAVA (p = 0.002), without differences between the two latter (p = 0.08). PIF (p = 0.109), EAdi peak (p = 0.931) and gas exchange were similar between modes. Compared to PS P and NAVA, PS N reduced PIF time (p < 0.001), and increased PTP 300-index (p = 0.004) and PTP 500-index (p = 0.001). NAVA and PS N significantly reduced Delay TR-insp , as opposed to PS P (p < 0.001). During both NAVA and PS N , AI% was <10% in all patients, while AI% was ≥10% in 7 patients (50%) with PS P (p = 0.023 compared with both NAVA and PS N )., Conclusions: Compared to both PS P and NAVA, PS N improved comfort and patient-ventilator interaction during NIV by facial mask. PS N also improved synchrony, as opposed to PS P only., Trial Registration: ClinicalTrials.gov, NCT03041402 . Registered (retrospectively) on 2 February 2017.

Background: Compared to pneumatically controlled pressure support (PSP), neurally adjusted ventilatory assist (NAVA) was proved to improve patient-ventilator interactions, while not affecting comfort, diaphragm electrical activity (EAdi), and arterial blood gases (ABGs). This study compares neurally controlled pressure support (PSN) with PSP and NAVA, delivered through two different helmets, in hypoxemic patients receiving noninvasive ventilation for prevention of extubation failure., Methods: Fifteen patients underwent three (PSP, NAVA, and PSN) 30-min trials in random order with both helmets. Positive end-expiratory pressure was always set at 10 cm H2O. In PSP, the inspiratory support was set at 10 cm H2O above positive end-expiratory pressure. NAVA was adjusted to match peak EAdi (EAdipeak) during PSP. In PSN, the NAVA level was set at maximum matching the pressure delivered during PSP by limiting the upper pressure. The authors assessed patient comfort, EAdipeak, rates of pressurization (i.e., airway pressure-time product [PTP] of the first 300 and 500 ms after the initiation of patient effort, indexed to the ideal pressure-time products), and measured ABGs., Results: PSN significantly increased comfort to (median [25 to 75% interquartile range]) 8 [7 to 8] and 9 [8 to 9] with standard and new helmets, respectively, as opposed to both PSP (5 [5 to 6] and 7 [6 to 7]) and NAVA (6 [5 to 7] and 7 [6 to 8]; P < 0.01 for all comparisons). Regardless of the interface, PSN also decreased EAdipeak (P < 0.01), while increasing PTP of the first 300 ms from the onset of patient effort, indexed to the ideal PTP (P < 0.01) and PTP of the first 500 ms from the onset of patient effort, indexed to the ideal PTP (P < 0.001). ABGs were not different among trials., Conclusions: When delivering noninvasive ventilation by helmet, compared to PSP and NAVA, PSN improves comfort and patient-ventilator interactions, while not ABGs. (Anesthesiology 2016; 125:1181-9).

Non-invasive ventilation (NIV) delivered in an intensive care unit (ICU) has become the cornerstone in the treatment of patients with severe chronic obstructive pulmonary disease (COPD) exacerbations. A trend towards managing these patients in non-ICU setting has emerged in recent years, although out-of-hospital survival by this approach and how to prognosticate it is unknown. We aimed to investigate these issues. We consecutively recruited 100 patients (49 males; median age 82 years) who received NIV treatment for acute respiratory failure due to COPD exacerbation in non-ICU medical wards of our hospital, between November 2008 and July 2012. We assessed survival (both in-hospital and out-of-hospital) of all these patients, and analyzed baseline parameters in a Cox proportional hazards model to develop a prognostic score. The median survival in the study population was 383 days (240-980). Overall survival rates were 71.0, 65.3, and 52.7 % at 1, 3, and 12 months, respectively. Age >85 years, a history of heart disorders and a neutrophil count ≥10 × 10(9) were associated with higher mortality at Cox's analysis (χ (2) = 35.766, p = 0.0001), and were used to build a prognostic score (NC85). The presence of two or more factors determined the deepest drop in survival (when NC85 ≥2, mortality at 1, 3, and 12 was 60.7, 70.4, and 77.2 %, respectively, while when NC85 = 0 were 4.0, 4.0, and 14.0 %). A simple model, based on three variables (age, neutrophil count and history of heart disease), accurately predicts survival of COPD patients receiving NIV in a non-ICU setting.

Background: The helmet is a well-tolerated interface for noninvasive ventilation, although it is associated with poor patient-ventilator interaction. A new helmet (NH) has proven to attenuate this limitation of the standard helmet (SH) in both bench study and healthy volunteers. The authors compared a NH and a SH in intensive care unit patients receiving noninvasive ventilation for prevention of postextubation respiratory failure; both helmets were also compared with the endotracheal tube in place before extubation., Methods: Fourteen patients underwent 30-min trials in pressure support during invasive ventilation and then with a SH and a NH in a random order. The authors measured comfort, triggering delays, rates of pressurization (airway pressure-time product [PTP] of the first 300 [PTP(300-index)] and 500 [PTP(500-index)] ms from the onset of effort, and the first 200 ms from the onset of insufflation [PTP200]), time of synchrony between effort and assistance (Time(synch)/Ti(neu)), respiratory drive and frequency, arterial blood gases (ABGs), and rate of asynchrony., Results: Compared with SH, NH improved comfort (5.5 [5.0 to 6.0] vs. 8.0 [7.8 to 8.0]), respectively, P < 0.001), inspiratory trigger delay (0.31 [0.22 to 0.43] vs. 0.25 [0.18 to 0.31] s, P = 0.007), and pressurization (PTP(300-index): 0.8 [0.1 to 1.8] vs. 2.7 [7.1 to 10.0]%; PTP(500-index): 4.8 [2.5 to 9.9] vs. 27.3 [16.2 to 34.8]%; PTP200: 13.6 [10.1 to 19.6] vs. 30.4 [24.9 to 38.4] cm H2O/s, P < 0.01 for all comparisons) and Time(synch)/Ti(neu) (0.64 [0.48 to 0.72] vs. 0.71 [0.61 to 0.81], P = 0.007). Respiratory drive and frequency, ABGs, and rate of asynchrony were not different between helmets. Endotracheal tube outperformed both helmets with respect to all variables, except for respiratory rate, ABGs, and asynchronies., Conclusions: Compared with a SH, a NH improved comfort and patient-ventilator interaction.

The choice of the interface for noninvasive ventilation (NIV) is a key factor in NIV success. We hypothesised that a new helmet specifically design to improve performance in hypercapnic patients would be clinically equivalent to a standard oronasal mask. In a multicentre, short-term, physiological, randomised trial in chronic obstructive pulmonary disease patients facing an acute hypercapnic respiratory failure episode, we compared the changes in arterial blood gases (ABGs) and tolerance score obtained using the helmet or mask, and, as secondary end-points, dyspnoea, vital signs, early NIV discontinuation and rate of intubation. 80 patients were randomly assigned to receive NIV either with the helmet (n=39) or mask (n=41), using an intensive care unit ventilator. Compared with baseline, in the first 6 h, NIV improved ABGs, dyspnoea and respiratory rate (p<0.05) in both groups. Changes in ABGs and discomfort were similar with the two groups, while dyspnoea decreased more (p<0.005) using the mask. The rate of intubation and the need for interface change during the whole period of NIV were very low and not different between groups. The new helmet may be a valid alternative to a mask in improving ABGs and achieving a good tolerance during an episode of acute hypercapnic respiratory failure., (Copyright ©ERS 2015.)

Background: Although noninvasive ventilation (NIV) is increasingly used in general wards, limited information exists about its ability to provide effective ventilation in this setting. We aim to evaluate NIV delivered in the ward by assessing (1) overall time of application and occurrence of adverse events and (2) differences between daytime and nighttime NIV application., Methods: We studied subjects with hypercapnic acute hypercapnic respiratory failure not fulfilling strict criteria for ICU admission, and excluded those who interrupted NIV prior to 48 h. Time spent on NIV, presence and extent of air leaks, and occurrence of desaturations were assessed for the overall study period, and compared between daytime and nighttime., Results: We enrolled 42 subjects, 25 of whom received NIV for at least 48 h and were included in the data analysis. NIV was successful for 20 subjects, who did not reach criteria for ICU admission. Both PaCO2 and pH significantly improved on average after 2 h and at the end of the study period. NIV was applied for 64.5% of the overall study period and had absent or compensated air leaks for 62.3% of the overall 48-h period. NIV was applied for 55.8% of daytime and for 79.3% of nighttime (P < .01). Effective NIV application was significantly longer overnight (76.9%) than during daytime (53.2%) (P < .01)., Conclusions: In selected subjects with hypercapnic acute respiratory failure not fulfilling criteria for ICU admission, the application of NIV in the ward is feasible; in addition, NIV can be safely administered overnight., (Copyright © 2015 by Daedalus Enterprises.)

Introduction: Interface choice is crucial for non-invasive ventilation (NIV) success. We compared a new interface, the helmet next (HN), with the facial mask (FM) and the standard helmet (HS) in twelve healthy volunteers., Methods: In this study, five NIV trials were randomly applied, preceded and followed by a trial of unassisted spontaneous breathing (SB). Baseline settings, for example, 5 cmH2O of both inspiratory pressure support (PS) and positive end-expiratory pressure (PEEP), were applied through FM, HS and HN, while increased settings (PS and PEEP of 8 cmH2O) were only applied through HS and HN. We measured flow, airway, esophageal and gastric pressures, and calculated inspiratory effort indexes and trigger delays. Comfort was assessed with a visual-analog-scale., Results: We found that FM, HS and HN at baseline settings were not significantly different with respect to inspiratory effort indexes and comfort. Inspiratory trigger delay and time of synchrony (TI,synchrony) were significantly improved by FM compared to both helmets, whereas expiratory trigger delay was shorter with FM, as opposed to HS only. HN at increased settings performed better than FM in decreasing inspiratory effort measured by pressure-time product of transdiaphragmatic pressure (PTPdi)/breath (10.7 ± 9.9 versus 17.0 ± 11.0 cmH2Os), and PTPdi/min (128 ± 96 versus 204 ± 81 cmH2Os/min), and PTPdi/L (12.6 ± 9.9 versus 30.2 ± 16.8 cmH2Os/L). TI, synchrony was inferior between HN and HS at increased settings and FM., Conclusions: HN might hold some advantages with respect to interaction and synchrony between subject and ventilator, but studies on patients are needed to confirm these findings., Trial Registration: ClinicalTrials.gov NCT01610960.

Objective: To evaluate the performance of a new helmet (NH) recently introduced into clinical use relative to that of the standard helmet (SH) in terms of delivering non-invasive continuous positive airway pressure (nCPAP) and pressure support ventilation (nPSV)., Design: This was a bench study using a mannequin connected to an active lung simulator. The SH was fastened to the mannequin by armpit braces, which are not needed to secure the NH., Measurements: The inspiratory and expiratory variations in nCPAP delivered with two different simulated efforts (Pmus), were determined relative to the preset CPAP level. nPSV was applied at two simulated respiratory rates (RR) and two cycling-off flow thresholds. We measured inspiratory trigger delay (Delay trinsp), expiratory trigger delay (Delay trexp), time of synchrony (Time sync), trigger pressure drop (ΔP trigger), airway pressure-time product during the triggering phase (PTPt), the initial 200 ms from the onset of the ventilator pressurization (PTP 200), and the initial 300 and 500 ms from the onset of the simulated effort; this two latter parameters were expressed as the percentage of the area of ideal pressurization (PTP 300-index and PTP 500-index, respectively)., Results: In nCPAP, at both Pmus, the differences between the two interfaces at both Pmus were small and clinically irrelevant. In nPSV, regardless of the setting, NH resulted in significantly smaller trigger delays, ΔP trigger, and PTPt. Time sync, PTP 200, PTP 300-index, and PTP 500-index were also significantly higher with the NH compared to the SH, irrespective of the setting., Conclusions: Compared to the SH, the NH is equally effective in delivering nCPAP and more effective in delivering nPSV, and it is used to avoid the need for armpit braces.

Background: The use of non-invasive ventilation (NIV) in acute hypoxemic respiratory failure (AHRF) due to H1N1 virus infection is controversial. In this multicenter study we aimed to assess the efficacy of NIV in avoiding endotracheal intubation (ETI) and to identify predictors of success or failure., Methods: In this prospective multicenter study, 98 patients with new pulmonary infiltrate(s) sustained by H1N1 virus and a PaO(2)/FiO2<300 were eligible for study; 38/98 required immediate ETI, while the others received NIV as a first line therapy; 13/60 patients failed NIV and were intubated after 5.8+5.5 hours from enrolment. The remaining 47/60 patients were successfully ventilated with NIV., Results: Hospital mortality was significantly higher in those patients who failed NIV vs. those who succeeded (53.8% vs. 2.1%; OR=0.52, P<0.001). ETI was associated with higher number of infectious complications, mainly sepsis and septic shock. The OR of having one of these events in the NIV failure group vs. NIV success was 16.7, P<0.001. According to logistic regression model, a SAPS II>29 and a PaO(2)/FIO(2)≤127 at admission and PaO2/FIO(2)≤149 after 1 hr of NIV were independently associated with the need for ETI., Conclusion: The early application of NIV, with the aim to avoid invasive ventilation, during the H1N1 pandemics was associated with an overall success rate of 47/98 (48%). Patients presenting at admission with an high SAPS II score and a low PaO(2)/FiO(2) ratio and/or unable to promptly correct gas exchange are at high risk of intubation and mortality.

Purpose: The use of noninvasive ventilation (NIV) to facilitate discontinuation of mechanical ventilation in patients with acute hypoxemic respiratory failure (hypoxemic ARF) has never been explored. This pilot study aims to assess the feasibility of early extubation followed by immediate NIV, compared conventional weaning, in patients with resolving hypoxemic ARF., Methods: Twenty consecutive hypoxemic patients were randomly assigned to receive either conventional weaning or NIV. The changes in arterial blood gases and respiratory rate were compared between the two groups at 1, 12, 24 and 48 h. Differences in the rate of extubation failure, ICU and hospital mortality, number of invasive-ventilation-free-days at day 28, septic complications, number of tracheotomies, days and rates of continuous intravenous sedation, and ICU length of stay were also determined., Results: No patient interrupted the study protocol. Arterial blood gases were similar during invasive mechanical ventilation, 1 h after NIV application following extubation, and after 12, 24 and 48 h. Respiratory rate was higher after 1 h in the NIV group, but no different after 12, 24 and 48 h. The number of invasive-ventilation-free-days at day 28 was 20 ± 8 (min = 0, max = 25) days in the treatment group and 10 ± 9 (min = 0, max = 25) days in the control group (p = 0.014). The rate of extubation failure, ICU and hospital mortality, tracheotomies, septic complications, days and rates of continuous sedation, and ICU length of stay were not significantly different between the two groups., Conclusions: In a highly experienced centre NIV may be used to facilitate discontinuation of mechanical ventilation in selected patients with resolving hypoxemic ARF.

Abstract Background In the last decades, noninvasive ventilation (NIV) has been increasingly used to support patients with hypercapnic and hypoxemic acute respiratory failure. Pressure ulcers are a frequently observed NIV-related adverse effect, directly related to interface type and exposure time. Switching to a different interface has been proposed as a solution to improve patient comfort. However, large studies investigating the benefit of this strategy are not available. Thus, the aim of the ROTAtional-USE of interface STUDY (ROTA-USE STUDY) is to investigate whether a protocolized rotational use of interfaces during NIV is effective in reducing the incidence of pressure ulcers. Methods The ROTA-USE STUDY is a pragmatic, parallel arm, open-label, multicenter, spontaneous, non-profit, randomized controlled trial requiring non-significant risk medical devices, with the aim to determine whether a rotational strategy of NIV interfaces is associated with a lower incidence of pressure ulcers compared to the standard of care. In the intervention group, NIV mask will be randomly chosen and rotated every 6 h. In the control group, mask will be chosen according to the standard of care of the participating centers and changed in case of discomfort or in the presence of new pressure sores. In both groups, the skin underneath the mask will be inspected every 12 h for any possible damage by blinded assessors. The primary outcome is the proportion of patients developing new pressure sores at 36 h from randomization. The secondary outcomes are (i) onset of pressure sores measured at different time points, i.e., 12, 24, 36, 48, 60, 72, 84, and 96 h; (ii) number and stage of pressure sores and comfort measured at 12, 24, 36, 48, 60, 72, 84, and 96 h; and (iii) the economic impact of the protocolized rotational use of interfaces. A sample size of 239 subjects per group (intervention and control) is estimated to detect a 10% absolute difference in the proportion of patients developing pressure sores at 36 h. Discussion The development of pressure ulcers is a common side effect of NIV that negatively affects the patients’ comfort and tolerance, often leading to NIV failure and adverse outcomes. The ROTA-USE STUDY will determine whether a protocolized rotational approach can reduce the incidence, number, and severity of pressure ulcers in NIV-treated patients. Trial registration ClinicalTrials.gov NCT05513508. Registered on August 24, 2022.

Abstract Background Noninvasive respiratory support (NIRS) has been diffusely employed outside the intensive care unit (ICU) to face the high request of ventilatory support due to the massive influx of patients with acute respiratory failure (ARF) caused by coronavirus-19 disease (COVID-19). We sought to summarize the evidence on clinically relevant outcomes in COVID-19 patients supported by NIV outside the ICU. Methods We searched PUBMED®, EMBASE®, and the Cochrane Controlled Clinical trials register, along with medRxiv and bioRxiv repositories for pre-prints, for observational studies and randomized controlled trials, from inception to the end of February 2021. Two authors independently selected the investigations according to the following criteria: (1) observational study or randomized clinical trials enrolling ≥ 50 hospitalized patients undergoing NIRS outside the ICU, (2) laboratory-confirmed COVID-19, and (3) at least the intra-hospital mortality reported. Preferred Reporting Items for Systematic reviews and Meta-analysis guidelines were followed. Data extraction was independently performed by two authors to assess: investigation features, demographics and clinical characteristics, treatments employed, NIRS regulations, and clinical outcomes. Methodological index for nonrandomized studies tool was applied to determine the quality of the enrolled studies. The primary outcome was to assess the overall intra-hospital mortality of patients under NIRS outside the ICU. The secondary outcomes included the proportions intra-hospital mortalities of patients who underwent invasive mechanical ventilation following NIRS failure and of those with ‘do-not-intubate’ (DNI) orders. Results Seventeen investigations (14 peer-reviewed and 3 pre-prints) were included with a low risk of bias and a high heterogeneity, for a total of 3377 patients. The overall intra-hospital mortality of patients receiving NIRS outside the ICU was 36% [30–41%]. 26% [21–30%] of the patients failed NIRS and required intubation, with an intra-hospital mortality rising to 45% [36–54%]. 23% [15–32%] of the patients received DNI orders with an intra-hospital mortality of 72% [65–78%]. Oxygenation on admission was the main source of between-study heterogeneity. Conclusions During COVID-19 outbreak, delivering NIRS outside the ICU revealed as a feasible strategy to cope with the massive demand of ventilatory assistance. Registration PROSPERO, https://www.crd.york.ac.uk/prospero/ , CRD42020224788, December 11, 2020.

Abstract Background Usefulness of noninvasive ventilation (NIV) in weaning patients with non-hypercapnic hypoxemic acute respiratory failure (hARF) is unclear. The study aims to assess in patients with non-hypercapnic hARF, the efficacy of NIV after early extubation, compared to standard weaning. Methods In this individual patient data meta-analysis, we searched EMBASE, Medline and Cochrane Central Register of Controlled Trials to identify potentially eligible randomized controlled trials published from database inception to October 2020. To be eligible, studies had to include patients treated with NIV after early extubation and compared to conventional weaning in adult non-hypercapnic hARF patients. Anonymized individual patient data from eligible studies were provided by study investigators. Using one-step and two-step meta-analysis models we tested the difference in total days spent on invasive ventilation. Results We screened 1605 records. Six studies were included in quantitative synthesis. Overall, 459 participants (mean [SD] age, 62 [15] years; 269 [59%] males) recovering from hARF were included in the analysis (233 in the intervention group and 226 controls). Participants receiving NIV had a shorter duration of invasive mechanical ventilation compared to control group (mean difference, − 3.43; 95% CI − 5.17 to − 1.69 days, p

Abstract Background The efficacy and safety of high flow nasal therapy (HFNT) in patients with acute hypercapnic exacerbation of chronic obstructive pulmonary disease (AECOPD) are unclear. Our aim was to evaluate the short-term effect of HFNT versus NIV in patients with mild-to-moderate AECOPD, with the hypothesis that HFNT is non-inferior to NIV on CO2 clearance after 2 h of treatment. Methods We performed a multicenter, non-inferiority randomized trial comparing HFNT and noninvasive ventilation (NIV) in nine centers in Italy. Patients were eligible if presented with mild-to-moderate AECOPD (arterial pH 7.25–7.35, PaCO2 ≥ 55 mmHg before ventilator support). Primary endpoint was the mean difference of PaCO2 from baseline to 2 h (non-inferiority margin 10 mmHg) in the per-protocol analysis. Main secondary endpoints were non-inferiority of HFNT to NIV in reducing PaCO2 at 6 h in the per-protocol and intention-to-treat analysis and rate of treatment changes. Results Seventy-nine patients were analyzed (80 patients randomized). Mean differences for PaCO2 reduction from baseline to 2 h were − 6.8 mmHg (± 8.7) in the HFNT and − 9.5 mmHg (± 8.5) in the NIV group (p = 0.404). By 6 h, 32% of patients (13 out of 40) in the HFNT group switched to NIV and one to invasive ventilation. HFNT was statistically non-inferior to NIV since the 95% confidence interval (CI) upper boundary of absolute difference in mean PaCO2 reduction did not reach the non-inferiority margin of 10 mmHg (absolute difference 2.7 mmHg; 1-sided 95% CI 6.1; p = 0.0003). Both treatments had a significant effect on PaCO2 reductions over time, and trends were similar between groups. Similar results were found in both per-protocol at 6 h and intention-to-treat analysis. Conclusions HFNT was statistically non-inferior to NIV as initial ventilatory support in decreasing PaCO2 after 2 h of treatment in patients with mild-to-moderate AECOPD, considering a non-inferiority margin of 10 mmHg. However, 32% of patients receiving HFNT required NIV by 6 h. Further trials with superiority design should evaluate efficacy toward stronger patient-related outcomes and safety of HFNT in AECOPD. Trial registration: The study was prospectively registered on December 12, 2017, in ClinicalTrials.gov (NCT03370666).

Abstract Background Noninvasive ventilation (NIV) is indicated to treat respiratory acidosis due to exacerbation of chronic obstructive pulmonary disease (COPD). Recent nonrandomized studies also demonstrated some physiological effects of high-flow nasal therapy (HFNT) in COPD patients. We designed a prospective, unblinded, multicenter, randomized controlled trial to assess the noninferiority of HFNT compared to NIV with respect to the reduction of arterial partial pressure of carbon dioxide (PaCO2) in patients with hypercapnic acute respiratory failure with mild-to-moderate respiratory acidosis. Methods We will enroll adult patients with acute hypercapnic respiratory failure, as defined by arterial pH between 7.25 and 7.35 and PaCO2 ≥ 55 mmHg. Patients will be randomly assigned 1:1 to receive NIV or HFNT. NIV will be applied through a mask with a dedicated ventilator in pressure support mode. Positive end-expiratory pressure will be set at 3–5 cmH2O with inspiratory support to obtain a tidal volume between 6 and 8 ml/kg of ideal body weight. HFNT will be initially set at a temperature of 37 °C and a flow of 60 L/min. At 2 and 6 h we will assess arterial blood gases, vital parameters, respiratory rate, treatment intolerance and failure, need for endotracheal intubation, time spent under mechanical ventilation (both invasive and NIV), intensive care unit and hospital length of stay, and hospital mortality. Based on an α error of 5% and a β error of 80%, with a standard deviation for PaCO2 equal to 15 mmHg and a noninferiority limit of 10 mmHg, we computed a sample size of 56 patients. Considering potential drop-outs and nonparametric analysis, the final computed sample size was 80 patients (40 per group). Discussion HFNT is more comfortable than NIV in COPD patients recovering from an episode of exacerbation. If HFNT would not be inferior to NIV, HFNT could be considered as an alternative to NIV to treat COPD patients with mild-to-moderate respiratory acidosis. Trial registration ClinicalTrials.gov, NCT03370666. Registered on December 12, 2017.

Abstract Background Noninvasive ventilation (NIV) is generally delivered using pneumatically-triggered and cycled-off pressure support (PSP) through a mask. Neurally adjusted ventilatory assist (NAVA) is the only ventilatory mode that uses a non-pneumatic signal, i.e., diaphragm electrical activity (EAdi), to trigger and drive ventilator assistance. A specific setting to generate neurally controlled pressure support (PSN) was recently proposed for delivering NIV by helmet. We compared PSN with PSP and NAVA during NIV using a facial mask, with respect to patient comfort, gas exchange, and patient-ventilator interaction and synchrony. Methods Three 30-minute trials of NIV were randomly delivered to 14 patients immediately after extubation to prevent post-extubation respiratory failure: (1) PSP, with an inspiratory support ≥8 cmH2O; (2) NAVA, adjusting the NAVA level to achieve a comparable peak EAdi (EAdipeak) as during PSP; and (3) PSN, setting the NAVA level at 15 cmH2O/μV with an upper airway pressure (Paw) limit to obtain the same overall Paw applied during PSP. We assessed patient comfort, peak inspiratory flow (PIF), time to reach PIF (PIFtime), EAdipeak, arterial blood gases, pressure-time product of the first 300 ms (PTP300-index) and 500 ms (PTP500-index) after initiation of patient effort, inspiratory trigger delay (DelayTR-insp), and rate of asynchrony, determined as asynchrony index (AI%). The categorical variables were compared using the McNemar test, and continuous variables by the Friedman test followed by the Wilcoxon test with Bonferroni correction for multiple comparisons (p

BACKGROUND: Noninvasive respiratory support (NRS) has been used to treat acute respiratory failure outside the ICU, but existing data have left many knowledge gaps for managing NRS in general wards. The primary objective of this study was to describe indications, duration of treatment, and outcomes of subjects treated with NRS outside the ICU. The secondary objective was to compare outcomes based on age < 80 or ≥ 80 y. METHODS: This retrospective observational study was conducted at Maggiore della Carita University Hospital in Novara, Italy, and included all patients treated with noninvasive ventilation (NIV) or CPAP outside the ICU from November 2017 to October 2018, with 1 year of follow-up. RESULTS: Of the 570 treatments performed, 383 subjects were analyzed, 136 NIV and 247 CPAP. Subjects' median (interquartile range [IQR]) age was 79 (72-85) y, and the main diagnoses of respiratory failure were cardiogenic pulmonary edema in 128 subjects (33%), pneumonia in 99 (26%), and COPD exacerbation in 52 (14%), with a median (IQR) treatment duration of 38 (16-74) h. Rapid response team visits lasted a median (IQR) 3 (2-6) d. Interface-related pressure lesions occurred in 13% of the subjects, in no case leading to definitive treatment discontinuation. Compared with the subjects ≥ 80 y old, the younger subjects had a median (IQR) longer hospitalization (16 [10-24] d vs 13 [9-20] d; P = .003) but slightly decreased in-hospital mortality (21% vs 30%; P = .061) and a decreased post-discharged 1-year mortality in hospital survivors (25% vs 41%; P = .002), differences observed only in the subjects treated with NIV. CONCLUSIONS: In a real-life setting outside the ICU, NIV and CPAP managed by a rapid response team with a daily visit in collaboration with ward staff highly experienced in NRS allowed us to treat the subjects without major complications. Post-discharge 1-year mortality was higher in the subjects ≥ 80 y old treated with NIV for acute hypercapnic respiratory failure. [ABSTRACT FROM AUTHOR]