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Core warming of coronavirus disease 2019 (COVID-19) patients undergoing mechanical ventilation-A protocol for a randomized controlled pilot study.

ABSTRACT: Background: Coronavirus disease 2019 (COVID-19), caused by the virus SARS-CoV-2, is spreading rapidly across the globe, with little proven effective therapy. Fever is seen in most cases of COVID-19, at least at the initial stages of illness. Although fever is typically treated (with antipyretics or directly with ice or other mechanical means), increasing data suggest that fever is a protective adaptive response that facilitates recovery from infectious illness.

Objective: To describe a randomized controlled pilot study of core warming patients with COVID-19 undergoing mechanical ventilation.

Methods: This prospective single-site randomized controlled pilot study will enroll 20 patients undergoing mechanical ventilation for respiratory failure due to COVID-19. Patients will be randomized 1:1 to standard-of-care or to receive core warming via an esophageal heat exchanger commonly utilized in critical care and surgical patients. The primary outcome is patient viral load measured by lower respiratory tract sample. Secondary outcomes include severity of acute respiratory distress syndrome (as measured by PaO2/FiO2 ratio) 24, 48, and 72 hours after initiation of treatment, hospital and intensive care unit length of stay, duration of mechanical ventilation, and 30-day mortality.

Results: Resulting data will provide effect size estimates to guide a definitive multi-center randomized clinical trial. ClinicalTrials.gov registration number: NCT04426344.

Conclusions: With growing data to support clinical benefits of elevated temperature in infectious illness, this study will provide data to guide further understanding of the role of active temperature management in COVID-19 treatment and provide effect size estimates to power larger studies.

SUBMITTER: Bonfanti N

PROVIDER: S-EPMC7707531 | biostudies-literature | 2020

REPOSITORIES: biostudies-literature

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Core warming of coronavirus disease 2019 (COVID-19) patients undergoing mechanical ventilation-A protocol for a randomized controlled pilot study.

Bonfanti Nathaniel N Gundert Emily E Drewry Anne M AM Goff Kristina K Bedimo Roger R Kulstad Erik E

PloS one 20201201 12

<h4>Background</h4>Coronavirus disease 2019 (COVID-19), caused by the virus SARS-CoV-2, is spreading rapidly across the globe, with little proven effective therapy. Fever is seen in most cases of COVID-19, at least at the initial stages of illness. Although fever is typically treated (with antipyretics or directly with ice or other mechanical means), increasing data suggest that fever is a protective adaptive response that facilitates recovery from infectious illness.<h4>Objective</h4>To describ ...[more]

PMID: 33259540

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Project description:Studying interhospital transfer of critically ill patients with coronavirus disease 2019 pneumonia in the spring 2020 surge may help inform future pandemic management.ObjectivesTo compare outcomes for mechanically ventilated patients with coronavirus disease 2019 transferred to a tertiary referral center with increased surge capacity with patients admitted from the emergency department.Design setting participantsObservational cohort study of single center urban academic medical center ICUs. All patients admitted and discharged with coronavirus disease 2019 pneumonia who received invasive ventilation between March 17, 2020, and October 14, 2020.Main outcome and measuresDemographic and clinical variables were obtained from the electronic medical record. Patients were classified as emergency department admits or interhospital transfers. Regression models tested the association between transfer status and survival, adjusting for demographics and presentation severity.ResultsIn total, 298 patients with coronavirus disease 2019 pneumonia were admitted to the ICU and received mechanical ventilation. Of these, 117 were transferred from another facility and 181 were admitted through the emergency department. Patients were primarily male (64%) and Black (38%) or Hispanic (45%). Transfer patients differed from emergency department admits in having English as a preferred language (71% vs 56%; p = 0.008) and younger age (median 57 vs 61 yr; p < 0.001). There were no differences in race/ethnicity or primary payor. Transfers were more likely to receive extracorporeal membrane oxygenation (12% vs 3%; p = 0.004). Overall, 50 (43%) transferred patients and 78 (43%) emergency department admits died prior to discharge. There was no significant difference in hospital mortality or days from intubation to discharge between the two groups.Conclusions and relevanceIn a single-center retrospective cohort, no significant differences in hospital mortality or length of stay between interhospital transfers and emergency department admits were found. While more study is needed, this suggests that interhospital transfer of critically ill patients with coronavirus disease 2019 can be done safely and effectively.

Project description:BackgroundPneumoperitoneum and Trendelenburg position in laparoscopic surgeries could contribute to postoperative pulmonary dysfunction. In recent years, intraoperative lung-protective mechanical ventilation (LPV) has been reportedly able to attenuate ventilator-induced lung injuries (VILI). Our objectives were to test the hypothesis that LPV could improve intraoperative oxygenation function, pulmonary mechanics and early postoperative atelectasis in laparoscopic surgeries.MethodsIn this randomized controlled clinical trial, 62 patients indicated for elective abdominal laparoscopic surgeries with an expected duration of greater than 2 h were randomly assigned to receive either lung-protective ventilation (LPV) with a tidal volume (Vt) of 7 ml kg- 1 ideal body weight (IBW), 10 cmH2O positive end-expiratory pressure (PEEP) combined with regular recruitment maneuvers (RMs) or conventional ventilation (CV) with a Vt of 10 ml kg- 1 IBW, 0 cmH2O in PEEP and no RMs. The primary endpoints were the changes in the ratio of PaO2 to FiO2 (P/F). The secondary endpoints were the differences between the two groups in PaO2, alveolar-arterial oxygen gradient (A-aO2), intraoperative pulmonary mechanics and the incidence of atelectasis detected on chest x-ray on the first postoperative day.ResultsIn comparison to CV group, the intraoperative P/F and PaO2 in LPV group were significantly higher while the intraoperative A-aO2 was clearly lower. Cdyn and Cstat at all the intraoperative time points in LPV group were significantly higher compared to CV group (p < 0.05). There were no differences in the incidence of atelectasis on day one after surgery between the two groups.ConclusionsLung protective mechanical ventilation significantly improved intraoperative pulmonary oxygenation function and pulmonary compliance in patients experiencing various abdominal laparoscopic surgeries, but it could not ameliorate early postoperative atelectasis and oxygenation function on the first day after surgery.Trial registrationhttps://www.clinicaltrials.gov/identifier: NCT04546932 (09/05/2020).

Project description:BackgroundA large proportion of patients with coronavirus disease 2019 (COVID-19) develop severe respiratory failure requiring admission to the intensive care unit (ICU) and about 80% of them need mechanical ventilation (MV). These patients show great complexity due to multiple organ involvement and a dynamic evolution over time; moreover, few information is available about the risk factors that may contribute to increase the time course of mechanical ventilation.The primary objective of this study is to investigate the risk factors associated with the inability to liberate COVID-19 patients from mechanical ventilation. Due to the complex evolution of the disease, we analyzed both pulmonary variables and occurrence of non-pulmonary complications during mechanical ventilation. The secondary objective of this study was the evaluation of risk factors for ICU mortality.MethodsThis multicenter prospective observational study enrolled 391 patients from fifteen COVID-19 dedicated Italian ICUs which underwent invasive mechanical ventilation for COVID-19 pneumonia. Clinical and laboratory data, ventilator parameters, occurrence of organ dysfunction, and outcome were recorded. The primary outcome measure was 28 days ventilator-free days and the liberation from MV at 28 days was studied by performing a competing risks regression model on data, according to the method of Fine and Gray; the event death was considered as a competing risk.ResultsLiberation from mechanical ventilation was achieved in 53.2% of the patients (208/391). Competing risks analysis, considering death as a competing event, demonstrated a decreased sub-hazard ratio for liberation from mechanical ventilation (MV) with increasing age and SOFA score at ICU admission, low values of PaO2/FiO2 ratio during the first 5 days of MV, respiratory system compliance (CRS) lower than 40 mL/cmH2O during the first 5 days of MV, need for renal replacement therapy (RRT), late-onset ventilator-associated pneumonia (VAP), and cardiovascular complications.ICU mortality during the observation period was 36.1% (141/391). Similar results were obtained by the multivariate logistic regression analysis using mortality as a dependent variable.ConclusionsAge, SOFA score at ICU admission, CRS, PaO2/FiO2, renal and cardiovascular complications, and late-onset VAP were all independent risk factors for prolonged mechanical ventilation in patients with COVID-19.Trial registrationNCT04411459.

Project description:BackgroundThere are large uncertainties with regard to the outcome of patients with coronavirus disease 2019 (COVID-19) and mechanical ventilation (MV). High mortality (50-97%) was proposed by some groups, leading to considerable uncertainties with regard to outcomes of critically ill patients with COVID-19.ObjectivesThe aim was to investigate the characteristics and outcomes of critically ill patients with COVID-19 requiring intensive care unit (ICU) admission and MV.MethodsA multicentre retrospective observational cohort study at 15 hospitals in Hamburg, Germany, was performed. Critically ill adult patients with COVID-19 who completed their ICU stay between February and June 2020 were included. Patient demographics, severity of illness, and ICU course were retrospectively evaluated.ResultsA total of 223 critically ill patients with COVID-19 were included. The majority, 73% (n = 163), were men; the median age was 69 (interquartile range = 58-77.5) years, with 68% (n = 151) patients having at least one chronic medical condition. Their Sequential Organ Failure Assessment score was a median of 5 (3-9) points on admission. Overall, 167 (75%) patients needed MV. Noninvasive ventilation and high-flow nasal cannula were used in 31 (14%) and 26 (12%) patients, respectively. Subsequent MV, due to noninvasive ventilation/high-flow nasal cannula therapy failure, was necessary in 46 (81%) patients. Renal replacement therapy was initiated in 33% (n = 72) of patients, and owing to severe respiratory failure, extracorporeal membrane oxygenation was necessary in 9% (n = 20) of patients. Experimental antiviral therapy was used in 9% (n = 21) of patients. Complications during the ICU stay were as follows: septic shock (40%, n = 90), heart failure (8%, n = 17), and pulmonary embolism (6%, n = 14). The length of ICU stay was a median of 13 days (5-24), and the duration of MV was 15 days (8-25). The ICU mortality was 35% (n = 78) and 44% (n = 74) among mechanically ventilated patients.ConclusionIn this multicentre observational study of 223 critically ill patients with COVID-19, the survival to ICU discharge was 65%, and it was 56% among patients requiring MV. Patients showed high rate of septic complications during their ICU stay.

Project description:ObjectivesAbout 5% of patients with coronavirus disease-2019 are admitted to the ICU for acute hypoxemic respiratory failure. Opinions differ on whether invasive mechanical ventilation should be used as first-line therapy over noninvasive oxygen support. The aim of the study was to assess the effect of early invasive mechanical ventilation in coronavirus disease-2019 with acute hypoxemic respiratory failure on day-60 mortality.DesignMulticenter prospective French observational study.SettingEleven ICUs of the French OutcomeRea network.PatientsCoronavirus disease-2019 patients with acute hypoxemic respiratory failure (Pao2/Fio2 ≤ 300 mm Hg), without shock or neurologic failure on ICU admission, and not referred from another ICU or intermediate care unit were included.InterventionWe compared day-60 mortality in patients who were on invasive mechanical ventilation within the first 2 calendar days of the ICU stay (early invasive mechanical ventilation group) and those who were not (nonearly invasive mechanical ventilation group). We used a Cox proportional-hazard model weighted by inverse probability of early invasive mechanical ventilation to determine the risk of death at day 60.Measurement and main resultsThe 245 patients included had a median (interquartile range) age of 61 years (52-69 yr), a Simplified Acute Physiology Score II score of 34 mm Hg (26-44 mm Hg), and a Pao2/Fio2 of 121 mm Hg (90-174 mm Hg). The rates of ICU-acquired pneumonia, bacteremia, and the ICU length of stay were significantly higher in the early (n = 117 [48%]) than in the nonearly invasive mechanical ventilation group (n = 128 [52%]), p < 0.01. Day-60 mortality was 42.7% and 21.9% in the early and nonearly invasive mechanical ventilation groups, respectively. The weighted model showed that early invasive mechanical ventilation increased the risk for day-60 mortality (weighted hazard ratio =1.74; 95% CI, 1.07-2.83, p=0.03).ConclusionsIn ICU patients admitted with coronavirus disease-2019-induced acute hypoxemic respiratory failure, early invasive mechanical ventilation was associated with an increased risk of day-60 mortality. This result needs to be confirmed.

Dataset Information

Core warming of coronavirus disease 2019 (COVID-19) patients undergoing mechanical ventilation-A protocol for a randomized controlled pilot study.

Publications

Core warming of coronavirus disease 2019 (COVID-19) patients undergoing mechanical ventilation-A protocol for a randomized controlled pilot study.

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