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 clinical trial. Adult patients with confirmed COVID-19, high-flow nasal oxygen or noninvasive ventilation for respiratory support and a PaO 2 /FiO 2 ratio ≤ 20 kPa were randomly assigned to a protocol targeting 16 h 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 h [IQR 1.8–8.4] in the control group compared with 9.0 h 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 The implemented 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 ISRCTN54917435. Registered 15 June 2020 ( https://doi.org/10.1186/ISRCTN54917435 ). Supplementary Information The online version contains supplementary material available at 10.1186/s13054-021-03602-9.
【저자키워드】 COVID-19, Critical care, Respiratory failure, intensive care, mechanical ventilation, Awake prone positioning, High-flow nasal oxygen, Noninvasive ventilation, Intubation rates, 【초록키워드】 randomized clinical trial, protocol, Respiratory failure, Trial, hospital, Awake prone positioning, High-flow nasal oxygen, Noninvasive ventilation, Intubation rates, intubation, oxygen, adverse events, Randomized, Patient, Ventilator-free days, multicenter, respiratory, 30-Day mortality, Hypoxemic respiratory failure, primary endpoint, Respiratory Support, prone positioning, Endotracheal intubation, moderate to severe, Intubated, Enrollment, Endpoint, pressure sores, control group, Trial registration, supplementary material, 95% CI, standard care, Secondary endpoints, Secondary outcomes, Adult patients, two patients, futility, eligibility, secondary outcome, prone group, intubation rate, implemented protocol, organ support, hypoxemic, secondary, Randomly, Result, conducted, per day, reduce, assigned, groups, did not reduce, Adult patient, PaO, patients with moderate, pressure sore, 【제목키워드】 randomized clinical trial, Patient, multicenter, hypoxemic,