Awake Prone Positioning in Patients with Hypoxemic Respiratory Failure Due to COVID-19: The PROFLO Multicenter Randomized Clinical Trial

Abstract

Background: The effect of awake prone positioning on intubation rates is not established. The aim of this trial was to investigate if a protocol for awake prone positioning reduces the rate of endotracheal intubation compared with standard care among patients with moderate to severe hypoxemic respiratory failure due to COVID-19. Methods: We conducted a multicenter randomized controlled trial. Adult patients with confirmed COVID-19, high-flow nasal oxygen or noninvasive ventilation for respiratory support and a PaO2/FiO2 ratio ≤ 20 kPa were randomly assigned to a protocol targeting 16 hours prone positioning per day or standard care. The primary endpoint was intubation within 30 days. Secondary endpoints included duration of awake prone positioning, 30-day mortality, ventilator free days, hospital and intensive care unit length of stay, use of noninvasive ventilation, organ support and adverse events. The trial was terminated early due to futility. Results: Of 141 patients assessed for eligibility, 75 were randomized of whom 39 were allocated to the control group and 36 to the prone group. Within 30 days after enrollment, 13 patients (33%) were intubated in the control group versus 12 patients (33%) in the prone group (HR 1.01 (95% CI 0.46-2.21), P=0.99). Median prone duration was 3.4 hours [IQR 1.8-8.4] in the control group compared with 9.0 hours per day [IQR 4.4-10.6] in the prone group (P=0.014). Nine patients (23%) in the control group had pressure sores compared with two patients (6%) in the prone group (difference -18% (95% CI -2% to -33%); P=0.032). There were no other differences in secondary outcomes between groups.Conclusions: A protocol for awake prone positioning increased duration of prone positioning, but did not reduce the rate of intubation in patients with hypoxemic respiratory failure due to COVID-19 compared to standard care.Trial registration: ISRCTN54918435. Registered 15 June 2020 (https://doi.org/10.1186/ISRCTN54917435)

Effect of Awake Prone Positioning in non-Intubated COVID-19 Patients with Acute Hypoxemic Respiratory Failure: A Systematic Review and Meta-Analysis

“…Finally, 22 studies with a total of 5146 patients were included in the meta-analysis. [21][22][23][24][25][30][31][32][33][34][35][36][37][38][39][40][41][42][43][44][45][46]…”

“…The sample size ranged from 20 to 1121 patients. Seven of these studies were RCTs, 21,22,24,25,[30][31][32] of which one was a randomized, controlled, multinational, metatrial. 21 The other fifteen were observational studies.…”

Mechanical Ventilation for COVID-19 Patients

“…In another multicenter, multifactorial trial, Rosén et al randomized patients not only to HFNO or NIV, but also to standard care (i.e., supine/semi-recumbent position) versus APP. 56 PaO 2 /FiO 2 at inclusion was again in the range of moderate-to-severe ARDS, and noninvasive supports had a failure rate of 33% in both standard care and proned patients, without differences in terms of need for intubation. Lastly, a recent review and meta-analysis by Kharat et al on prone positioning in intubated and nonintubated patients showed a reduction in intubation rate for patients undergoing APP outside the ICU (OR: 0.60 [95% CI: 0.38–0.95]) and a reduction in mortality when APP was applied in the ICU (OR: 0.49 [95% CI: 0.32–0.77]).…”

Folgeschäden durch Beatmung in Bauchlage bei COVID-19 und ihre Relevanz für die Frührehabilitation – eine retrospektive Kohortenstudie

“…Zur Sicherstellung einer ausreichenden Oxygenierung bei ARDS hat sich neben nichtinvasiver Beatmung (NIV), High-Flow-Sauerstofftherapie und invasiver Beatmung die BL als effektive Therapiesäule etabliert 2 5 6 . Neue prospektive Daten aus randomisiert kontrollierten Studien zur Behandlung von COVID-19-Patient:innen mit ARDS zeigen vorteilhafte Effekte einer zusätzlichen BL bereits während der Phase nichtinvasiver Beatmung 7 8 9 . In der S3-Leitlinie zur stationären Therapie von COVID-19 wird bei High-Flow-Sauerstofftherapie und CPAP („continuous positive airway pressure“)/NIV zusätzlich eine BL empfohlen 9 .…”