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INTRODUCTION: Since the early pandemic, prone positioning (PP) has been broadly utilized for non-intubated COVID-19 patients, but results from recently published randomized controlled trials (RCTs) are contradictory. We aimed to systematically synthesize the outcomes associated with PP for non-intubated COVID-19 patients. METHOD(S): Two independent groups of researchers searched MEDLINE, Embase, PubMed, Web of Science, Scopus, and ClinicalTrials.gov for RCTs of PP in nonintubated adult patients with COVID-19 and published in English from January 1st, 2020 to July 1st, 2022. The same two independent groups extracted the data and assessed the risk of bias. We used a random-effects meta-analysis to pool individual studies and the GRADE approach to assess certainty/quality of the evidence. The primary outcome was the reported cumulative intubation risk, while secondary outcomes included mortality, need for escalating respiratory support, hospital length of stay, ICU admission, and adverse events. The study protocol was prospectively registered with PROSPERO, CRD42022343625. RESULT(S): 12 RCTs with 2,886 patients were included. For non-intubated COVID-19 patients, PP significantly reduced the intubation risk (risk ratio [RR] 0.85, 95%CI 0.75 to 0.96), compared to supine position. Subgroup analysis showed a significant reduction in intubation risk among patients supported by high-flow nasal cannula (HFNC) or noninvasive ventilation (NIV) (RR 0.83, 95%CI 0.73 to 0.94) but not in patients with conventional oxygen therapy (RR 1.02, 95%CI 0.67 to 1.56). No significant reduction was seen in mortality (RR 0.96, 95%CI 0.82 to 1.13), need for escalating respiratory support (RR 1.03, 95%CI 0.77 to 1.37), hospital length of stay (MD 0.35 days, 95%CI -0.57 to 1.26), ICU admission (RR 0.75, 95%CI 0.51 to 1.10), and adverse events. No obvious risk of bias and publication bias was found for the primary outcome. CONCLUSION(S): In non-intubated COVID-19 patients, PP reduced the need for intubation, in particular among those requiring respiratory support with HFNC or NIV, but did not reduce mortality, need for escalating respiratory support, hospital length of stay, and ICU admission.
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OBJECTIVE: We determined the prevalences of hyperoxemia and excessive oxygen use, and the epidemiology, ventilation characteristics and outcomes associated with hyperoxemia in invasively ventilated patients with coronavirus disease 2019 (COVID-19). METHODS: Post hoc analysis of a national, multicentre, observational study in 22 ICUs. Patients were classified in the first two days of invasive ventilation as 'hyperoxemic' or 'normoxemic'. The co-primary endpoints were prevalence of hyperoxemia (PaO2 > 90 mmHg) and prevalence of excessive oxygen use (FiO2 ≥ 60% while PaO2 > 90 mmHg or SpO2 > 92%). Secondary endpoints included ventilator settings and ventilation parameters, duration of ventilation, length of stay (LOS) in ICU and hospital, and mortality in ICU, hospital, and at day 28 and 90. We used propensity matching to control for observed confounding factors that may influence endpoints. RESULTS: Of 851 COVID-19 patients, 225 (26.4%) were classified as hyperoxemic. Excessive oxygen use occurred in 385 (45.2%) patients. Acute respiratory distress syndrome (ARDS) severity was lowest in hyperoxemic patients. Hyperoxemic patients were ventilated with higher positive end-expiratory pressure (PEEP), while rescue therapies for hypoxemia were applied more often in normoxemic patients. Neither in the unmatched nor in the matched analysis were there differences between hyperoxemic and normoxemic patients with regard to any of the clinical outcomes. CONCLUSION: In this cohort of invasively ventilated COVID-19 patients, hyperoxemia occurred often and so did excessive oxygen use. The main differences between hyperoxemic and normoxemic patients were ARDS severity and use of PEEP. Clinical outcomes were not different between hyperoxemic and normoxemic patients.
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BACKGROUND: It is uncertain whether awake prone positioning can prevent intubation for invasive ventilation in spontaneous breathing critically ill patients with acute hypoxemic respiratory failure. Awake prone positioning could benefit these patients for various reasons, including a reduction in direct harm to lung tissue, and prevention of tracheal intubation-related complications. DESIGN AND METHODS: The PRONELIFE study is an investigator-initiated, international, multicenter, randomized clinical trial in patients who may need invasive ventilation because of acute hypoxemic respiratory failure. Consecutive patients admitted to participating ICUs are randomly assigned to standard care with awake prone positioning, versus standard care without awake prone positioning. The primary endpoint is a composite of tracheal intubation and all-cause mortality in the first 14 days after enrolment. Secondary endpoints include time to tracheal intubation and effects of awake prone positioning on oxygenation parameters, dyspnea sensation, and complications. Other endpoints are the number of days free from ventilation and alive at 28 days, total duration of use of noninvasive respiratory support, total duration of invasive ventilation, length of stay in ICU and hospital, and mortality in ICU and hospital, and at 28, 60, and 90 days. We will also collect data regarding the tolerance of prone positioning. DISCUSSION: The PRONELIFE study is among the first randomized clinical trials investigating the effect of awake prone positioning on intubation rate in ICU patients with acute hypoxemic failure from any cause. The PRONELIFE study is sufficiently sized to determine the effect of awake prone positioning on intubation for invasive ventilation-patients are eligible in case of acute hypoxemic respiratory failure without restrictions regarding etiology. The PRONELIFE study is a pragmatic trial in which blinding is impossible-however, as around 35 ICUs worldwide will participate in this study, its findings will be highly generalizable. The findings of the PRONELIFE study have the potential to change clinical management of patients who may need invasive ventilation because of acute hypoxemic respiratory failure. TRIAL REGISTRATION: ISRCTN ISRCTN11536318 . Registered on 17 September 2021. The PRONELIFE study is registered at clinicaltrials.gov with reference number NCT04142736 (October, 2019).
Subject(s)
COVID-19 , Respiratory Insufficiency , Humans , Intensive Care Units , Multicenter Studies as Topic , Prone Position , Randomized Controlled Trials as Topic , WakefulnessABSTRACT
Objectives: Analyze the outcomes of our series of patients with COVID-19 supported with ECMO during pandemic and to identify the variables associated with outcomes. Methods: Prospective observational study including all the COVID-19 patients with ECMO support in the ICU of the VHUH from 15 March to 30 July. ECMO was considered if PaO2/FIO2 <80 mmHg, refractory to prone position, and/or PaCO2 >80 mmHg and pH <7.25 for >6h. Continuous variables expressed as median (ICR) and categorical variables as number (percentage). Differences in variables were analyzed using Chi Square test or T-test, as appropriate. Univariate logistic regression analysis was used to determine predictors of ICU mortality. Results: Twenty-four patients [55 (46-57) years, 58% male, BMI 32.1 (27-35)] with a PaO2/FIO2 of 66 (60-71) mmHg received ECMO support, 23 (96%) venovenous. Mechanical ventilation (MV) time prior to cannulation ranged from 1 to 17 days. Fifteen (63%) patients suffered hemorrhagic complications and 12 (48%) thrombotic events. These complications were not associated with a significant increase of mortality (P=1.0 and P=0.6, respectively). Eighteen (75%) patients could be decannulated and 16 (67%) were discharged alive from the ICU. Longer time on MV before cannulation was associated with a higher risk for ICU death (OR 1.31 [ICR 1.11-1.67];p=0.02). We found an association between age and mortality, but it did not reach significance (OR 1.05 [ICR 1.0-1.25];p= 0.36). Conclusions: ECMO may be useful in those COVID-19 patients with refractory hypoxemia. Time on MV prior to cannulation should be considered when indicating the technique.