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Fever is a recognized protective factor in patients with sepsis, and growing data suggest beneficial effects on outcomes in sepsis with elevated temperature, with a recent pilot randomized controlled trial showing lower mortality by warming afebrile sepsis patients in the intensive care unit. The objective of this prospective single-site randomized controlled trial was to determine if core warming improves respiratory physiology of mechanically ventilated patients with COVID-19, allowing earlier weaning from ventilation, and greater overall survival. A total of 19 patients with mean age of 60.5 (±12.5) years, 37% female, mean weight 95.1 (±18.6) kg, and mean BMI 34.5 (±5.9) kg/m2 with COVID-19 requiring mechanical ventilation were enrolled from September 2020 through February 2022. Patients were randomized 1:1 to standard-of-care or to receive core warming for 72 hours via an esophageal heat exchanger commonly utilized in critical care and surgical patients. The maximum target temperature was 39.8 °C. A total of 10 patients received usual care and 9 patients received esophageal core warming. After 72 hours of warming, PaO2/FiO2 ratios were 197 (±32) and 134 (±13.4), Cycle Thresholds were 30.8 (±6.4) and 31.4 (±3.2), ICU mortality was 40% and 44%, 30-day mortality was 30% and 22%, and mean 30-day ventilator-free days were 11.9 (±12.6) and 6.8 (±10.2) for standard-of-care and warmed patients, respectively (p=NS). This pilot study suggests that core warming of patients with COVID-19 undergoing mechanical ventilation is feasible and appears safe. Optimizing time to achieve febrile-range temperature may require a multimodal temperature management strategy to further evaluate effects on outcome.

Neutralizing antibody plays a key role in protective immunity against COVID-19. As increasingly distinct variants circulate, debate continues regarding the value of adding novel variants to SARS-CoV-2 vaccines. In this study, we have analyzed live virus neutralization titers against WA1, Delta, BA.1, BA.2, and BA.5 in 187 hospitalized patients infected with Delta or Omicron strains. This information will be useful in selection of the SARS-CoV-2 strains to include in an updated vaccine. Our results show that unvaccinated Delta infected patients made a highly biased neutralizing antibody response towards the infecting Delta strain with slightly lower responses against the WA1 strain, but with strikingly lower titers against BA.1, BA.2, and BA.5. Delta infected patients that had been previously vaccinated with the WA1 containing COVID vaccine made equivalent responses to WA1 and Delta strains, but still had very low neutralizing antibody responses to Omicron strains. In striking contrast, both unvaccinated and vaccinated Omicron patients exhibited a more balanced ratio of Omicron virus neutralization compared to neutralization of ancestral strains. Interestingly, Omicron patients infected with BA.1 or BA.2 had detectable neutralizing antibody titers to BA.5, but these titers were lower than neutralization titers to BA.1 and BA.2. Taken together, these results suggest that inclusion of the Omicron BA.5 strain in a SARS-CoV-2 vaccine would be beneficial in protection against the widely circulating BA.5 variant.DisclaimerThe findings and conclusions in this report are those of the authors and do not necessarily represent the official position of the Centers for Disease Control and Prevention.

To compare the effectiveness of a primary covid-19 vaccine series plus booster doses with a primary series alone for the prevention of hospital admission with omicron related covid-19 in the United States.Multicenter observational case-control study with a test negative design.Hospitals in 18 US states.4760 adults admitted to one of 21 hospitals with acute respiratory symptoms between 26 December 2021 and 30 June 2022, a period when the omicron variant was dominant. Participants included 2385 (50.1%) patients with laboratory confirmed covid-19 (cases) and 2375 (49.9%) patients who tested negative for SARS-CoV-2 (controls).The main outcome was vaccine effectiveness against hospital admission with covid-19 for a primary series plus booster doses and a primary series alone by comparing the odds of being vaccinated with each of these regimens versus being unvaccinated among cases versus controls. Vaccine effectiveness analyses were stratified by immunosuppression status (immunocompetent, immunocompromised). The primary analysis evaluated all covid-19 vaccine types combined, and secondary analyses evaluated specific vaccine products.Overall, median age of participants was 64 years (interquartile range 52-75 years), 994 (20.8%) were immunocompromised, 85 (1.8%) were vaccinated with a primary series plus two boosters, 1367 (28.7%) with a primary series plus one booster, and 1875 (39.3%) with a primary series alone, and 1433 (30.1%) were unvaccinated. Among immunocompetent participants, vaccine effectiveness for prevention of hospital admission with omicron related covid-19 for a primary series plus two boosters was 63% (95% confidence interval 37% to 78%), a primary series plus one booster was 65% (58% to 71%), and for a primary series alone was 37% (25% to 47%) (P0.001 for the pooled boosted regimens compared with a primary series alone). Vaccine effectiveness was higher for a boosted regimen than for a primary series alone for both mRNA vaccines (BNT162b2 (Pfizer-BioNTech): 73% (44% to 87%) for primary series plus two boosters, 64% (55% to 72%) for primary series plus one booster, and 36% (21% to 48%) for primary series alone (P0.001); mRNA-1273 (Moderna): 68% (17% to 88%) for primary series plus two boosters, 65% (55% to 73%) for primary series plus one booster, and 41% (25% to 54%) for primary series alone (P=0.001)). Among immunocompromised patients, vaccine effectiveness for a primary series plus one booster was 69% (31% to 86%) and for a primary series alone was 49% (30% to 63%) (P=0.04).During the first six months of 2022 in the US, booster doses of a covid-19 vaccine provided additional benefit beyond a primary vaccine series alone for preventing hospital admissions with omicron related covid-19.This article is a living test negative design study that will be updated to reflect emerging evidence. Updates may occur for up to two years from the date of original publication.

ObjectiveTo test the hypothesis that provider-to-provider tele-emergency department (tele-ED) care is associated with more 28-day hospital-free days and improved Surviving Sepsis Campaign (SSC) guideline adherence in rural emergency departments (EDs).MethodsMulticenter (n=23), propensity-matched, cohort study using medical records of sepsis patients from rural hospitals in a well-established, on-demand, rural video tele-ED network in the upper Midwest between August 2016 and June 2019. The primary outcome was 28-day hospital-free days, with secondary outcomes of 28-day in-hospital mortality and SSC guideline adherence.ResultsA total of 1,191 patients were included in the analysis, with tele-ED used for 326 (27%). Tele-ED cases were more likely to be transferred to another hospital (88% vs. 8%, difference 79%, 95% CI 75–83%). After matching and regression adjustment, tele-ED cases did not have more 28-day hospital-free days (difference 0.80 days longer for non-tele-ED, 95% confidence interval [CI] [-0.87]–2.47) or 28-day in-hospital mortality (adjusted odds ratio [aOR] 1.61, 95% CI 0.74-3.57). Adherence with both the SSC 3-hour bundle (aOR 0.80, 95% CI 0.24– 2.70) and complete bundle (aOR 0.81, 95% CI 0.15–4.41) were similar. An a priori–defined subgroup analysis of patients treated by advanced practice providers suggested that the mortality was lower in the cohort with tele-ED use (aOR 0.19, 95% CI 0.04–0.90) despite no significant difference in complete SSC bundle adherence (aOR 2.48, 95% CI 0.45–13.76).ConclusionsRural ED patients treated with provider-to-provider tele-ED care in a mature network appear to have similar clinical outcomes to those treated without.

In comparison to the general patient population, trauma patients show higher level detections of bloodborne infectious diseases, such as Hepatitis and Human Immunodeficiency Virus. In comparison to bloodborne pathogens, the prevalence of respiratory infections such as SARS-CoV-2 and how that relates with other variables, such as drug usage and trauma type, is currently unknown in trauma populations. Here, we evaluated SARS-CoV-2 seropositivity and antibody isotype profile in 2,542 trauma patients from six Level-1 trauma centers between April and October of 2020 during the first wave of the COVID-19 pandemic. We found that the seroprevalence in trauma victims 18-44 years old (9.79%, 95% confidence interval/CI: 8.33 11.47) was much higher in comparison to older patients (45-69 years old: 6.03%, 4.59-5.88; 70+ years old: 4.33%, 2.54 – 7.20). Black/African American (9.54%, 7.77 – 11.65) and Hispanic/Latino patients (14.95%, 11.80 – 18.75) also had higher seroprevalence in comparison, respectively, to White (5.72%, 4.62 7.05) and Non-Latino patients (6.55%, 5.57 – 7.69). More than half (55.54%) of those tested for drug toxicology had at least one drug present in their system. Those that tested positive for narcotics or sedatives had a significant negative correlation with seropositivity, while those on anti-depressants trended positive. These findings represent an important consideration for both the patients and first responders that treat trauma patients facing potential risk of respiratory infectious diseases like SARS-CoV-2.

BackgroundAs SARS-CoV-2 vaccination coverage increases in the United States (US), there is a need to understand the real-world effectiveness against severe Covid-19 and among people at increased risk for poor outcomes.MethodsIn a multicenter case-control analysis of US adults hospitalized March 11 - May 5, 2021, we evaluated vaccine effectiveness to prevent Covid-19 hospitalizations by comparing odds of prior vaccination with an mRNA vaccine (Pfizer-BioNTech or Moderna) between cases hospitalized with Covid-19 and hospital-based controls who tested negative for SARS-CoV-2.ResultsAmong 1210 participants, median age was 58 years, 22.8% were Black, 13.8% were Hispanic, and 20.6% had immunosuppression. SARS-CoV-2 lineage B.1.1.7 was most common variant (59.7% of sequenced viruses). Full vaccination (receipt of two vaccine doses ≥14 days before illness onset) had been received by 45/590 (7.6%) cases and 215/620 (34.7%) controls. Overall vaccine effectiveness was 86.9% (95% CI: 80.4 to 91.2%). Vaccine effectiveness was similar for Pfizer-BioNTech and Moderna vaccines, and highest in adults aged 18-49 years (97.3%; 95% CI: 78.9 to 99.7%). Among 45 patients with vaccine-breakthrough Covid hospitalizations, 44 (97.8%) were ≥50 years old and 20 (44.4%) had immunosuppression. Vaccine effectiveness was lower among patients with immunosuppression (59.2%; 95% CI: 11.9 to 81.1%) than without immunosuppression (91.3%; 95% CI: 85.5 to 94.7%).ConclusionDuring March–May 2021, SARS-CoV-2 mRNA vaccines were highly effective for preventing Covid-19 hospitalizations among US adults. SARS-CoV-2 vaccination was beneficial for patients with immunosuppression, but effectiveness was lower in the immunosuppressed population.

ObjectiveSepsis is a common cause of death in hospitalized patients. The Centers for Medicare & Medicaid Service (CMS) Severe Sepsis and Septic Shock Bundle (SEP-1) is an evidence-based early management bundle focused on improving sepsis outcomes. It is unknown which quality improvement (QI) practices are associated with SEP-1 compliance and if those practices reduce sepsis mortality. The objectives of this study were to compare sepsis QI practices in SEP-1 reporting and non-reporting hospitals and to measure the association between specific elements of sepsis QI processes and SEP-1 performance and hospital-specific risk-adjusted sepsis mortality.Design, Setting, and PatientsThis mixed methods study linked telephone survey data on QI practices from Iowa hospitals to SEP-1 performance data and risk-adjusted mortality from statewide all-payer administrative claims database. The survey assessed sepsis QI practices in eight categories. Characteristics of hospitals and sepsis QI practices were compared by SEP-1 reporting status. Univariable and multivariable logistic and linear regression estimated the association of QI practices with hospital SEP-1 performance and observed-to-expected sepsis mortality ratios.InterventionsNoneMeasurements and Main ResultsAll 118 Iowa hospitals completed the survey (100% response rate). SEP-1 reporting hospitals were more likely to have sepsis QI practices, including reporting sepsis quality to providers (64% vs. 38%, p = 0.026) and using the case review process to develop sepsis care plans (87% vs. 64%, p = 0.013). Sepsis QI practices were not associated with increased SEP-1 scores. Two were associated with reduced mortality: having a sepsis committee β= -0.11, p = 0.036) and using case review results for sepsis care plans (β= -0.10, p = 0.049).ConclusionsHospitals reporting SEP-1 compliance to CMS conduct more sepsis QI practices. Most QI practices are not associated with increased SEP-1 performance or decreased sepsis mortality. Future work could explore how to implement these performance improvement practices in hospitals not reporting SEP-1 compliance.

ObjectiveThis research sought to assess the level of COVID-19 preparedness of Emergency Departments (EDs) in Aotearoa New Zealand (NZ) through the views of Emergency Medicine specialists working in District Health Boards around the country. Given the limited experience NZ hospitals have had with SARS-CoV-2, a comparison of current local practice with recent literature from other countries identifying known weaknesses may help prevent future healthcare worker infections in NZ. MethodsA cross-sectional survey by convenience sample of New Zealand Emergency Specialists in November 2020 to evaluate preparedness of engineering, administrative policy, and PPE use. ResultsA total of 137 surveys were completed (32% response rate), revealing heterogeneity in NZ ED clinical work environments in November 2020. More than 10% of emergency specialists surveyed reported no access to negative pressure rooms. N95 fit testing was not done on 15 (11%). Most specialists (86%) work in EDs that cohort patients, about one-third (34%) do not use spotters during PPE doffing, few have policy regarding breaches in PPE, and most do not have required space for physical distancing in non-clinical areas. Initial PPE training, simulations and segregating patients were widespread but appear to be waning with persistent low SARS-CoV-2 prevalence. PPE shortages were not identified in NZ EDs, yet 13% of consultants did not indicate they would use respirators during aerosol generating procedures on COVID-19 patients. Treatment interventions including non-invasive ventilation and high flow nasal cannula were common. Many respondents reported high levels of stress attributable to predicted inadequate staffing and the state of overall preparedness in event of a second wave. ConclusionsNew Zealand emergency specialists identified significant gaps in COVID-19 preparedness, and they have a unique opportunity to translate lessons from other locations into local action. Proactive identification of weaknesses in hospital engineering, policy, and PPE practice in advance of future SARS-CoV-2 endemic transmission would be prudent. What is already known?Aotearoa New Zealand has eliminated COVID-19 community transmission. Recently, trans-Tasman neighbour Australia has controlled SARS-CoV-2 surges which were complicated by significant nosocomial spread and healthcare worker infections. Several recent publications as well as expert recommendations from the Australian Department of Health and Human Services have listed improvements to the Hierarchy of Controls necessary to prevent future outbreaks in hospitals and long-term care facilities. What are the new findings?Survey responses specifically identified breakdowns in engineering, administrative policy and PPE in New Zealand emergency departments (EDs), potentially increasing healthcare worker nosocomial infection risk. As of November 2020, equitable access of all NZ emergency specialists to recommended negative flow rooms, fit testing of N95 masks, and other evidence based policy upgrades to COVID-19 infection prevention and control (IPC) standards are not universal. What do the new findings imply?The experience of local emergency specialists in a rapidly evolving pandemic can identify weaknesses in emergency preparedness previously reported to have increased nosocomial infection risk in similar healthcare environments. The aim of this research was to identify those weaknesses in local NZ emergency department policy, protocols and PPE and further efforts to provide proactive recommendations for system improvement. Finally, the research sought to understand how safe NZ emergency specialists felt during the initial lockdown and provides insight as to the psychological experiences of this vital group of front-line staff.

BackgroundThroughout 2020, the coronavirus disease 2019 (COVID-19) has become a threat to public health on national and global level. There has been an immediate need for research to understand the clinical signs and symptoms of COVID-19 that can help predict deterioration including mechanical ventilation, organ support, and death. Studies thus far have addressed the epidemiology of the disease, common presentations, and susceptibility to acquisition and transmission of the virus; however, an accurate prognostic model for severe manifestations of COVID-19 is still needed because of the limited healthcare resources available.ObjectiveThis systematic review aims to evaluate published reports of prediction models for severe illnesses caused COVID-19.MethodsSearches were developed by the primary author and a medical librarian using an iterative process of gathering and evaluating terms. Comprehensive strategies, including both index and keyword methods, were devised for PubMed and EMBASE. The data of confirmed COVID-19 patients from randomized control studies, cohort studies, and case-control studies published between January 2020 and July 2020 were retrieved. Studies were independently assessed for risk of bias and applicability using the Prediction Model Risk Of Bias Assessment Tool (PROBAST). We collected study type, setting, sample size, type of validation, and outcome including intubation, ventilation, any other type of organ support, or death. The combination of the prediction model, scoring system, performance of predictive models, and geographic locations were summarized.ResultsA primary review found 292 articles relevant based on title and abstract. After further review, 246 were excluded based on the defined inclusion and exclusion criteria. Forty-six articles were included in the qualitative analysis. Inter observer agreement on inclusion was 0.86 (95% confidence interval: 0.79 - 0.93). When the PROBAST tool was applied, 44 of the 46 articles were identified to have high or unclear risk of bias, or high or unclear concern for applicability. Two studied reported prediction models, 4C Mortality Score from hospital data and QCOVID from general public data from UK, and were rated as low risk of bias and low concerns for applicability.ConclusionSeveral prognostic models are reported in the literature, but many of them had concerning risks of biases and applicability. For most of the studies, caution is needed before use, as many of them will require external validation before dissemination. However, two articles were found to have low risk of bias and low applicability can be useful tools.

Study Objective: The COVID-19 pandemic has resulted in widespread shortages in personal protective equipment, including N95 respirators. While basic surgical facemasks are more commonly available, their efficacy is limited due primarily to their poor face seal. This pilot study examined the impact of a rubber band mask brace on a basic surgical mask, as determined by quantitative fit testing. Methods: Subjects wearing a basic surgical facemask and the rubber band mask brace underwent quantitative fit testing using machinery designed to certify N95 mask fit. Subjects were tested with the brace anchored behind their eyes, with a paperclip behind the head, and on the side knobs of their face shields. The primary outcome measure was whether the subject passed the quantitative fit test at or above the OSHA verified standard for N95 masks. Results: Subjects (n=11) were 54.5% female, with a median height of 70 inches (IQR 68-74), weight of 170 lbs (IQR 145-215) and BMI of 24.6 (IQR 22.2-27.2), and encompassing 5 distinct N95 mask fit types. We found that 45%, 100% and 100% of subjects passed the quantitative fit test when the brace was anchored behind the ears, with a paperclip and on a face shield respectively. Conclusion: Of the 11 subjects included in the analysis, across a range of body habitus and N95 mask fit types, all passed the quantitative fit test when the mask brace was anchored on either face shield or with a paperclip. This data suggests the brace would offer an improved margin of safety when worn with a basic surgical mask.