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3.
JAMA ; 327(21): 2104-2113, 2022 06 07.
Article in English | MEDLINE | ID: covidwho-1843811

ABSTRACT

Importance: The efficacy and safety of prone positioning is unclear in nonintubated patients with acute hypoxemia and COVID-19. Objective: To evaluate the efficacy and adverse events of prone positioning in nonintubated adult patients with acute hypoxemia and COVID-19. Design, Setting, and Participants: Pragmatic, unblinded randomized clinical trial conducted at 21 hospitals in Canada, Kuwait, Saudi Arabia, and the US. Eligible adult patients with COVID-19 were not intubated and required oxygen (≥40%) or noninvasive ventilation. A total of 400 patients were enrolled between May 19, 2020, and May 18, 2021, and final follow-up was completed in July 2021. Intervention: Patients were randomized to awake prone positioning (n = 205) or usual care without prone positioning (control; n = 195). Main Outcomes and Measures: The primary outcome was endotracheal intubation within 30 days of randomization. The secondary outcomes included mortality at 60 days, days free from invasive mechanical ventilation or noninvasive ventilation at 30 days, days free from the intensive care unit or hospital at 60 days, adverse events, and serious adverse events. Results: Among the 400 patients who were randomized (mean age, 57.6 years [SD, 12.83 years]; 117 [29.3%] were women), all (100%) completed the trial. In the first 4 days after randomization, the median duration of prone positioning was 4.8 h/d (IQR, 1.8 to 8.0 h/d) in the awake prone positioning group vs 0 h/d (IQR, 0 to 0 h/d) in the control group. By day 30, 70 of 205 patients (34.1%) in the prone positioning group were intubated vs 79 of 195 patients (40.5%) in the control group (hazard ratio, 0.81 [95% CI, 0.59 to 1.12], P = .20; absolute difference, -6.37% [95% CI, -15.83% to 3.10%]). Prone positioning did not significantly reduce mortality at 60 days (hazard ratio, 0.93 [95% CI, 0.62 to 1.40], P = .54; absolute difference, -1.15% [95% CI, -9.40% to 7.10%]) and had no significant effect on days free from invasive mechanical ventilation or noninvasive ventilation at 30 days or on days free from the intensive care unit or hospital at 60 days. There were no serious adverse events in either group. In the awake prone positioning group, 21 patients (10%) experienced adverse events and the most frequently reported were musculoskeletal pain or discomfort from prone positioning (13 of 205 patients [6.34%]) and desaturation (2 of 205 patients [0.98%]). There were no reported adverse events in the control group. Conclusions and Relevance: In patients with acute hypoxemic respiratory failure from COVID-19, prone positioning, compared with usual care without prone positioning, did not significantly reduce endotracheal intubation at 30 days. However, the effect size for the primary study outcome was imprecise and does not exclude a clinically important benefit. Trial Registration: ClinicalTrials.gov Identifier: NCT04350723.


Subject(s)
COVID-19 , Intubation, Intratracheal , Prone Position , Respiratory Insufficiency , Wakefulness , Adult , Aged , COVID-19/complications , COVID-19/therapy , Female , Humans , Hypoxia/etiology , Hypoxia/therapy , Intubation, Intratracheal/methods , Male , Middle Aged , Respiration, Artificial/methods , Respiratory Distress Syndrome/etiology , Respiratory Distress Syndrome/therapy , Respiratory Insufficiency/etiology , Respiratory Insufficiency/therapy
4.
J Cardiothorac Vasc Anesth ; 36(8 Pt B): 2975-2982, 2022 Aug.
Article in English | MEDLINE | ID: covidwho-1830213

ABSTRACT

OBJECTIVES: To assess the efficacy of an awake venovenous extracorporeal membrane oxygenation (VV-ECMO) management strategy in preventing clinically relevant barotrauma in patients with coronavirus disease 2019 (COVID-19) with severe acute respiratory distress syndrome (ARDS) at high risk for pneumothorax (PNX)/pneumomediastinum (PMD), defined as the detection of the Macklin-like effect on chest computed tomography (CT) scan. DESIGN: A case series. SETTING: At the intensive care unit of a tertiary-care institution. PARTICIPANTS: Seven patients with COVID-19-associated severe ARDS and Macklin-like radiologic sign on baseline chest CT. INTERVENTIONS: Primary VV-ECMO under spontaneous breathing instead of invasive mechanical ventilation (IMV). All patients received noninvasive ventilation or oxygen through a high-flow nasal cannula before and during ECMO support. The study authors collected data on cannulation strategy, clinical management, and outcome. Failure of awake VV-ECMO strategy was defined as the need for IMV due to worsening respiratory failure or delirium/agitation. The primary outcome was the development of PNX/PMD. MEASUREMENTS AND MAIN RESULTS: No patient developed PNX/PMD. The awake VV-ECMO strategy failed in 1 patient (14.3%). Severe complications were observed in 4 (57.1%) patients and were noted as the following: intracranial bleeding in 1 patient (14.3%), septic shock in 2 patients (28.6%), and secondary pulmonary infections in 3 patients (42.8%). Two patients died (28.6%), whereas 5 were successfully weaned off VV-ECMO and were discharged home. CONCLUSIONS: VV-ECMO in awake and spontaneously breathing patients with severe COVID-19 ARDS may be a feasible and safe strategy to prevent the development of PNX/PMD in patients at high risk for this complication.


Subject(s)
Barotrauma , COVID-19 , Extracorporeal Membrane Oxygenation , Respiratory Distress Syndrome , Barotrauma/epidemiology , Barotrauma/etiology , COVID-19/complications , COVID-19/therapy , Extracorporeal Membrane Oxygenation/methods , Humans , Respiratory Distress Syndrome/diagnostic imaging , Respiratory Distress Syndrome/etiology , Respiratory Distress Syndrome/therapy , Wakefulness
5.
JAMA Intern Med ; 182(6): 612-621, 2022 Jun 01.
Article in English | MEDLINE | ID: covidwho-1798074

ABSTRACT

Importance: Awake prone positioning may improve hypoxemia among patients with COVID-19, but whether it is associated with improved clinical outcomes remains unknown. Objective: To determine whether the recommendation of awake prone positioning is associated with improved outcomes among patients with COVID-19-related hypoxemia who have not received mechanical ventilation. Design, Setting, and Participants: This pragmatic nonrandomized controlled trial was conducted at 2 academic medical centers (Vanderbilt University Medical Center and NorthShore University HealthSystem) during the COVID-19 pandemic. A total of 501 adult patients with COVID-19-associated hypoxemia who had not received mechanical ventilation were enrolled from May 13 to December 11, 2020. Interventions: Patients were assigned 1:1 to receive either the practitioner-recommended awake prone positioning intervention (intervention group) or usual care (usual care group). Main Outcomes and Measures: Primary outcome analyses were performed using a bayesian proportional odds model with covariate adjustment for clinical severity ranking based on the World Health Organization ordinal outcome scale, which was modified to highlight the worst level of hypoxemia on study day 5. Results: A total of 501 patients (mean [SD] age, 61.0 [15.3] years; 284 [56.7%] were male; and most [417 (83.2%)] were self-reported non-Hispanic or non-Latinx) were included. Baseline severity was comparable between the intervention vs usual care groups, with 170 patients (65.9%) vs 162 patients (66.7%) receiving oxygen via standard low-flow nasal cannula, 71 patients (27.5%) vs 62 patients (25.5%) receiving oxygen via high-flow nasal cannula, and 16 patients (6.2%) vs 19 patients (7.8%) receiving noninvasive positive-pressure ventilation. Nursing observations estimated that patients in the intervention group spent a median of 4.2 hours (IQR, 1.8-6.7 hours) in the prone position per day compared with 0 hours (IQR, 0-0.7 hours) per day in the usual care group. On study day 5, the bayesian posterior probability of the intervention group having worse outcomes than the usual care group on the modified World Health Organization ordinal outcome scale was 0.998 (posterior median adjusted odds ratio [aOR], 1.63; 95% credibility interval [CrI], 1.16-2.31). However, on study days 14 and 28, the posterior probabilities of harm were 0.874 (aOR, 1.29; 95% CrI, 0.84-1.99) and 0.673 (aOR, 1.12; 95% CrI, 0.67-1.86), respectively. Exploratory outcomes (progression to mechanical ventilation, length of stay, and 28-day mortality) did not differ between groups. Conclusions and Relevance: In this nonrandomized controlled trial, prone positioning offered no observed clinical benefit among patients with COVID-19-associated hypoxemia who had not received mechanical ventilation. Moreover, there was substantial evidence of worsened clinical outcomes at study day 5 among patients recommended to receive the awake prone positioning intervention, suggesting potential harm. Trial Registration: ClinicalTrials.gov Identifier: NCT04359797.


Subject(s)
COVID-19 , Adult , Bayes Theorem , COVID-19/therapy , Female , Humans , Hypoxia/etiology , Hypoxia/therapy , Male , Middle Aged , Oxygen , Pandemics , Prone Position , Respiration, Artificial , Wakefulness
8.
Crit Care ; 26(1): 84, 2022 03 28.
Article in English | MEDLINE | ID: covidwho-1765461

ABSTRACT

BACKGROUND: Awake prone positioning (APP) improves oxygenation in coronavirus disease (COVID-19) patients and, when successful, may decrease the risk of intubation. However, factors associated with APP success remain unknown. In this secondary analysis, we aimed to assess whether APP can reduce intubation rate in patients with COVID-19 and to focus on the factors associated with success. METHODS: In this multicenter randomized controlled trial, conducted in three high-acuity units, we randomly assigned patients with COVID-19-induced acute hypoxemic respiratory failure (AHRF) requiring high-flow nasal cannula (HFNC) oxygen to APP or standard care. Primary outcome was intubation rate at 28 days. Multivariate analyses were performed to identify the predictors associated to treatment success (survival without intubation). RESULTS: Among 430 patients randomized, 216 were assigned to APP and 214 to standard care. The APP group had a lower intubation rate (30% vs 43%, relative risk [RR] 0.70; CI95 0.54-0.90, P = 0.006) and shorter hospital length of stay (11 interquartile range [IQR, 9-14] vs 13 [IQR, 10-17] days, P = 0.001). A respiratory rate ≤ 25 bpm at enrollment, an increase in ROX index > 1.25 after first APP session, APP duration > 8 h/day, and a decrease in lung ultrasound score ≥ 2 within the first 3 days were significantly associated with treatment success for APP. CONCLUSION: In patients with COVID-19-induced AHRF treated by HFNC, APP reduced intubation rate and improved treatment success. A longer APP duration is associated with APP success, while the increase in ROX index and decrease in lung ultrasound score after APP can also help identify patients most likely to benefit. TRIAL REGISTRATION: This study was retrospectively registered in ClinicalTrials.gov at July 20, 2021. Identification number NCT04477655. https://clinicaltrials.gov/ct2/show/NCT04477655?term=PRO-CARF&draw=2&rank=1.


Subject(s)
COVID-19 , Respiratory Insufficiency , COVID-19/complications , COVID-19/therapy , Cannula , Humans , Prone Position , Respiratory Insufficiency/complications , Respiratory Insufficiency/therapy , Wakefulness
9.
ASAIO J ; 68(4): 478-485, 2022 04 01.
Article in English | MEDLINE | ID: covidwho-1764692

ABSTRACT

Cessation of continuous analgesia and sedation in patients with acute respiratory distress syndrome (ARDS) receiving venovenous (VV) extracorporeal membrane oxygenation (ECMO) facilitates early extubation, family, patient and provider engagement, and mobility. Outcomes associated with an awake ECMO strategy have not been well described in the literature. The purpose of this study was to evaluate outcomes in patients receiving this strategy. This was a retrospective review of ARDS patients receiving awake VV ECMO. The primary outcome was survival to hospital discharge. Secondary outcomes included days requiring ECMO, time from cannulation to extubation, complications, patients requiring tracheostomy, hospital and intensive care unit (ICU) length of stay (LOS), and discharge disposition. In a subgroup analysis, outcomes were compared between non-COVID and COVID ECMO patients. Sixty-two patients were included with a survival to hospital discharge of 85.5%. Days requiring ECMO was 33.0 (0.0-75.0) and cannulation to extubation was 6.0 (4.0-11.0). Three patients received a tracheostomy (4.8%). Bleeding and infection were reported in 80.6% and 82.3% of patients, respectively. Intensive care unit length of stay was 46.0 days (29.0-90.0) and hospital LOS was 51.0 days (32.0-91.0). Over half of the patients (51.6%) were discharged to an acute rehabilitation facility and 27.4% were discharged home. There was similar survival to hospital discharge between the COVID and non-COVID awake ECMO patients (85% in both groups, p = 1.000). This study highlights the impact of an awake ECMO approach on survival to hospital discharge. Future studies are needed to evaluate this approach as compared to current practice to determine if this should become the standard.


Subject(s)
COVID-19 , Extracorporeal Membrane Oxygenation , Respiratory Distress Syndrome , Airway Extubation/adverse effects , COVID-19/therapy , Extracorporeal Membrane Oxygenation/adverse effects , Humans , Retrospective Studies , Wakefulness
11.
Eur Rev Med Pharmacol Sci ; 26(5): 1761-1764, 2022 Mar.
Article in English | MEDLINE | ID: covidwho-1754185

ABSTRACT

OBJECTIVE: In the past few years, extracorporeal membrane oxygenation (ECMO) has been increasingly used in patients with severe respiratory insufficiency in whom mechanical ventilation (MV) had failed. MV in severe COVID-19 patients is often accompanied by high respiratory pressures and high oxygen concentrations. Thus, by "placing the lungs at rest" ECMO might spare severe COVID-19 patients from being subjected to aggressive MV. Awake ECMO is another therapeutic alternative for providing extracorporeal oxygenation and ventilation by avoiding the complications of MV. CASE PRESENTATION: A 65-year-old male diagnosed with COVID-19 pneumonia was admitted to the intensive care unit (ICU) after deteriorating to hypoxemic respiratory failure with acute respiratory distress disorder (ARDS). Awake veno-venous (VV) ECMO was considered after receiving patient consent and was successfully implemented as an attempt to avoid invasive MV. This is one of the first cases described during the COVID-19 pandemic, in which awake VV-ECMO was used in a critically ill COVID-19 patient as a replacement therapy to conventional MV. CONCLUSIONS: Under the appropriate conditions, awake ECMO might be a suitable alternative approach to avoid complications of aggressive MV in selected critically ill COVID-19 ARDS patients.


Subject(s)
COVID-19/therapy , Extracorporeal Membrane Oxygenation/methods , Hypoxia/therapy , Pneumonia/therapy , Respiratory Insufficiency/therapy , Aged , Critical Care , Critical Illness , Humans , Male , Oxygen/blood , Respiratory Distress Syndrome , Treatment Outcome , Wakefulness
12.
Lancet Respir Med ; 10(6): 573-583, 2022 Jun.
Article in English | MEDLINE | ID: covidwho-1740330

ABSTRACT

BACKGROUND: Awake prone positioning has been broadly utilised for non-intubated patients with COVID-19-related acute hypoxaemic respiratory failure, but the results from published randomised controlled trials (RCTs) in the past year are contradictory. We aimed to systematically synthesise the outcomes associated with awake prone positioning, and evaluate these outcomes in relevant subpopulations. METHODS: In this systematic review and meta-analysis, two independent groups of researchers searched MEDLINE, Embase, PubMed, Web of Science, Scopus, MedRxiv, BioRxiv, and ClinicalTrials.gov for RCTs and observational studies (with a control group) of awake prone positioning in patients with COVID-19-related acute hypoxaemic respiratory failure published in English from Jan 1, 2020, to Nov 8, 2021. We excluded trials that included patients intubated before or at enrolment, paediatric patients (ie, younger than 18 years), or trials that did not include the supine position in the control group. The same two independent groups screened studies, extracted the summary data from published reports, and assessed the risk of bias. We used a random-effects meta-analysis to pool individual studies. We used the Grading of Recommendations Assessment, Development, and Evaluation approach to assess the certainty and quality of the evidence. The primary outcome was the reported cumulative intubation risk across RCTs, and effect estimates were calculated as risk ratios (RR;95% CI). The analysis was primarily conducted on RCTs, and observational studies were used for sensitivity analyses. No serious adverse events associated with awake prone positioning were reported. The study protocol was prospectively registered with PROSPERO, CRD42021271285. FINDINGS: A total of 1243 studies were identified, we assessed 138 full-text articles and received the aggregated results of three unpublished RCTs; therefore, after exclusions, 29 studies were included in the study. Ten were RCTs (1985 patients) and 19 were observational studies (2669 patients). In ten RCTs, awake prone positioning compared with the supine position significantly reduced the need for intubation in the overall population (RR 0·84 [95% CI 0·72-0·97]). A reduced need for intubation was shown among patients who received advanced respiratory support (ie, high-flow nasal cannula or non-invasive ventilation) at enrolment (RR 0·83 [0·71-0·97]) and in intensive care unit (ICU) settings (RR 0·83 [0·71-0·97]) but not in patients receiving conventional oxygen therapy (RR 0·87 [0·45-1·69]) or in non-ICU settings (RR 0·88 [0·44-1·76]). No obvious risk of bias and publication bias was found among the included RCTs for the primary outcome. INTERPRETATION: In patients with COVID-19-related acute hypoxaemic respiratory failure, awake prone positioning reduced the need for intubation, particularly among those requiring advanced respiratory support and those in ICU settings. Awake prone positioning should be used in patients who have acute hypoxaemic respiratory failure due to COVID-19 and require advanced respiratory support or are treated in the ICU. FUNDING: OpenAI, Rice Foundation, National Institute for Health Research, and Oxford Biomedical Research Centre.


Subject(s)
COVID-19 , Respiratory Insufficiency , COVID-19/complications , Child , Humans , Patient Positioning/methods , Prone Position , Respiratory Insufficiency/etiology , Respiratory Insufficiency/therapy , Wakefulness
14.
J Infect Public Health ; 15(4): 480-485, 2022 Apr.
Article in English | MEDLINE | ID: covidwho-1709324

ABSTRACT

BACKGROUND: Limited effective interventions exist in the emergency department (ED) for COVID-19 patients with respiratory failure. One of the promising interventions is the prone position, which has been proven to improve oxygenation in ICU settings. Here, we aimed to describe and assess the utility of the prone position in awake non-intubated adult patients in EDs during the COVID-19 pandemic. METHODS: We conducted a prospective cohort study of hypoxic COVID-19 adult patients who presented to our emergency department. We collected the data from June to the end of August 2020, including vital signs and physiological and clinical parameters before and after completing the four-hour prone position protocol. The main outcomes assessed were improvement in oxygenation, respiratory rate, respiratory distress score, ICU admission, and intubation. Oxygenation was calculated based on the standard pulse oximeter saturation [SpO2]/fractional concentration of oxygen in inspired air (FiO2). RESULTS: The study included 49 patients (81.63% men; mean age, 53.37 ± 11 years). The mean oxygen saturation during the triage was 84.49% ± 7.98 on room air. After completing of the four-hour prone protocol, the mean SpO2/FiO2 ratio increased from 1.62 ± 0.78-1.99 ± 0.75 (p < 0.0001). The respiratory rate decreased from 32.45 ± 5.24-26.29 ± 5.40 (p < 0.0001). Respiratory distress scores decreased after changing patients' positions (p < 0.0001). Twenty-four patients (48.9%) were admitted to the ICU, 6 patients were intubated (12.2%), and 7 (14.3%) died in the hospital. CONCLUSION: After applying the prone position in the ED, significant and immediate improvement was observed in oxygenation, respiratory rate, respiratory distress, and carbon dioxide levels. A linear relationship between the level of improvement in oxygenation and reduction in ICU admission was observed. However, further studies recommended to assess the advantage of the procedure in terms of ICU admission, intubation, or mortality.


Subject(s)
COVID-19 , Respiratory Distress Syndrome , Adult , COVID-19/therapy , Emergency Service, Hospital , Female , Humans , Male , Middle Aged , Pandemics , Prone Position/physiology , Prospective Studies , Wakefulness
15.
Med Intensiva (Engl Ed) ; 46(2): 65-71, 2022 02.
Article in English | MEDLINE | ID: covidwho-1693115

ABSTRACT

OBJECTIVE: Continuous positive airway pressure (CPAP) is an important therapeutic tool in COVID-19 acute respiratory distress syndrome (ARDS) since it improves oxygenation, reduces respiratory rate and can prevent intubation and intensive care unit (ICU) admission. CPAP during pronation has seldom been described and never during sedation. DESIGN: Case series. SETTING: High dependency unit of San Carlo University Hospital (Potenza, Italy). PATIENTS: Eleven consecutive patients with COVID-19 ARDS. INTERVENTION: Helmet CPAP in prone position after failing a CPAP trial in the supine position. MAIN VARIABLE OF INTEREST: Data collection at baseline and then after 24, 48 and 72h of pronation. We measured PaO2/FIO2, pH, lactate, PaCO2, SpO2, respiratory rate and the status of the patients at 28-day follow up. RESULTS: Patients were treated with helmet CPAP for a mean±SD of 7±2.7 days. Prone positioning was feasible in all patients, but in 7 of them dexmedetomidine improved comfort. PaO2/FIO2 improved from 107.5±20.8 before starting pronation to 244.4±106.2 after 72h (p<.001). We also observed a significantly increase in Sp02 from 90.6±2.3 to 96±3.1 (p<.001) and a decrease in respiratory rate from 27.6±4.3 to 20.1±4.7 (p=.004). No difference was observed in PaCO2 or pH. At 28 days two patients died after ICU admission, one was discharged in the main ward after ICU admission and eight were discharged home after being successfully managed outside the ICU. CONCLUSIONS: Helmet CPAP during pronation was feasible and safe in COVID-19 ARDS managed outside the ICU and sedation with dexmedetomidine safely improved comfort. We recorded an increase in PaO2/FIO2, SpO2 and a reduction in respiratory rate.


Subject(s)
COVID-19 , Respiratory Distress Syndrome , Continuous Positive Airway Pressure , Humans , Intensive Care Units , Pronation , Respiratory Distress Syndrome/therapy , SARS-CoV-2 , Wakefulness
17.
Trials ; 23(1): 30, 2022 Jan 10.
Article in English | MEDLINE | ID: covidwho-1635629

ABSTRACT

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 , Wakefulness
19.
Lancet Respir Med ; 9(12): 1387-1395, 2021 12.
Article in English | MEDLINE | ID: covidwho-1621129

ABSTRACT

BACKGROUND: Awake prone positioning has been reported to improve oxygenation for patients with COVID-19 in retrospective and observational studies, but whether it improves patient-centred outcomes is unknown. We aimed to evaluate the efficacy of awake prone positioning to prevent intubation or death in patients with severe COVID-19 in a large-scale randomised trial. METHODS: In this prospective, a priori set up and defined, collaborative meta-trial of six randomised controlled open-label superiority trials, adults who required respiratory support with high-flow nasal cannula for acute hypoxaemic respiratory failure due to COVID-19 were randomly assigned to awake prone positioning or standard care. Hospitals from six countries were involved: Canada, France, Ireland, Mexico, USA, Spain. Patients or their care providers were not masked to allocated treatment. The primary composite outcome was treatment failure, defined as the proportion of patients intubated or dying within 28 days of enrolment. The six trials are registered with ClinicalTrials.gov, NCT04325906, NCT04347941, NCT04358939, NCT04395144, NCT04391140, and NCT04477655. FINDINGS: Between April 2, 2020 and Jan 26, 2021, 1126 patients were enrolled and randomly assigned to awake prone positioning (n=567) or standard care (n=559). 1121 patients (excluding five who withdrew from the study) were included in the intention-to-treat analysis. Treatment failure occurred in 223 (40%) of 564 patients assigned to awake prone positioning and in 257 (46%) of 557 patients assigned to standard care (relative risk 0·86 [95% CI 0·75-0·98]). The hazard ratio (HR) for intubation was 0·75 (0·62-0·91), and the HR for mortality was 0·87 (0·68-1·11) with awake prone positioning compared with standard care within 28 days of enrolment. The incidence of prespecified adverse events was low and similar in both groups. INTERPRETATION: Awake prone positioning of patients with hypoxaemic respiratory failure due to COVID-19 reduces the incidence of treatment failure and the need for intubation without any signal of harm. These results support routine awake prone positioning of patients with COVID-19 who require support with high-flow nasal cannula. FUNDING: Open AI inc, Rice Foundation, Projet Hospitalier de Recherche Clinique Interrégional, Appel d'Offre 2020, Groupement Interrégional de Recherche Clinique et d'Innovation Grand Ouest, Association pour la Promotion à Tours de la Réanimation Médicale, Fond de dotation du CHRU de Tours, Fisher & Paykel Healthcare Ltd.


Subject(s)
COVID-19 , Patient Positioning , Prone Position , Respiratory Insufficiency , Adult , COVID-19/therapy , Canada , France , Humans , Ireland , Mexico , Prospective Studies , Respiratory Insufficiency/therapy , SARS-CoV-2 , Spain , Treatment Outcome , United States , Wakefulness
20.
Crit Care ; 26(1): 16, 2022 01 07.
Article in English | MEDLINE | ID: covidwho-1613247

ABSTRACT

BACKGROUND: In patients with COVID-19-related acute respiratory failure (ARF), awake prone positioning (AW-PP) reduces the need for intubation in patients treated with high-flow nasal oxygen (HFNO). However, the effects of different exposure times on clinical outcomes remain unclear. We evaluated the effect of AW-PP on the risk of endotracheal intubation and in-hospital mortality in patients with COVID-19-related ARF treated with HFNO and analyzed the effects of different exposure times to AW-PP. METHODS: This multicenter prospective cohort study in six ICUs of 6 centers in Argentine consecutively included patients > 18 years of age with confirmed COVID-19-related ARF requiring HFNO from June 2020 to January 2021. In the primary analysis, the main exposure was awake prone positioning for at least 6 h/day, compared to non-prone positioning (NON-PP). In the sensitivity analysis, exposure was based on the number of hours receiving AW-PP. Inverse probability weighting-propensity score (IPW-PS) was used to adjust the conditional probability of treatment assignment. The primary outcome was endotracheal intubation (ETI); and the secondary outcome was hospital mortality. RESULTS: During the study period, 580 patients were screened and 335 were included; 187 (56%) tolerated AW-PP for [median (p25-75)] 12 (9-16) h/day and 148 (44%) served as controls. The IPW-propensity analysis showed standardized differences < 0.1 in all the variables assessed. After adjusting for other confounders, the OR (95% CI) for ETI in the AW-PP group was 0.36 (0.2-0.7), with a progressive reduction in OR as the exposure to AW-PP increased. The adjusted OR (95% CI) for hospital mortality in the AW-PP group ≥ 6 h/day was 0.47 (0.19-1.31). The exposure to prone positioning ≥ 8 h/d resulted in a further reduction in OR [0.37 (0.17-0.8)]. CONCLUSION: In the study population, AW-PP for ≥ 6 h/day reduced the risk of endotracheal intubation, and exposure ≥ 8 h/d reduced the risk of hospital mortality.


Subject(s)
COVID-19 , Oxygen Inhalation Therapy , Respiratory Insufficiency , Administration, Intranasal , COVID-19/complications , Humans , Oxygen/administration & dosage , Oxygen Inhalation Therapy/methods , Prone Position , Prospective Studies , Respiratory Insufficiency/therapy , Respiratory Insufficiency/virology , Time Factors , Treatment Outcome , Wakefulness
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