Awake prone positioning effectiveness in moderate to severe COVID-19 a randomized controlled trial.
Authors: Phong Nguyen Thanh , Duc Du Hong , Hai Ho Bich , Nguyen Nguyen Thanh , Khoa Le Dinh Van , Khanh Le Thuy Thuy , Tran Luu Hoai Bao , Linh Nguyen Thi My , Van Cao Thi Cam , Thao Dang Phuong , Trinh Nguyen Thi Diem , Kieu Pham Tieu , Truong Nguyen Thanh , Hoang Vo Tan , Ngoc Nguyen Thanh , Vien Tran Thi Dong , Ly Vo Trieu , Khoa Tran Dang , Beane Abigail , Anibal James ,   OUCRU COVID RESEACH GROUP, Thwaites Guy E , Geskus Ronald , Clifton David , Dung Nguyen Thi Phuong , Kestelyn Evelyne , Glover Guy , Tan Le Van , Yen Lam Minh , Tung Nguyen Le Nhu , Dung Nguyen Thanh , Thwaites C Louise 
Published: September 2024

Background Awake prone positioning (APP) may be beneficial in patients with respiratory failure who are not receiving mechanical ventilation. Randomized controlled trials of APP have been performed during peak COVID-19 periods in unvaccinated populations, with limited data on compliance or patient acceptability. We aimed to evaluate the efficacy and acceptability of APP in a lower-middle income country in an open-label randomized controlled trial using a dedicated APP implementation team and wearable continuous-monitoring devices. Methods The trial was performed at a tertiary level hospital in Ho Chi Minh City, Vietnam, recruiting adults (≥18 years) hospitalized with moderate or severe COVID-19 and receiving supplemental oxygen therapy via nasal/facemask systems or high-flow nasal cannula (HFNC). Patients were allocated by a computer-generated random number sequence in a 1:1 ratio to standard care or APP, where a dedicated team provided bedside support. Wearable devices continuously recorded pulse oximetry and body position continuously. Our primary outcome was escalation of respiratory support within 28 days of randomization. Results Ninety-three patients were enrolled in this study between March 2022 and March 2023. Eighty (86%) patients had received ≥2 doses of SARS-CoV2 vaccine. The study was terminated early because of a reduction in the number of eligible patients. Data from 46 patients allocated to APP and 47 to standard care were available for analysis. At baseline, 19/47 (40%) patients allocated to the standard care group and 14/46 (30%) patients allocated to the APP group received HFNC. Continuous monitoring data were available for all patients monitored with wearable devices. Significantly greater mean daily APP times were achieved in those allocated to APP, however, most achieved less than the target 8 h/day. We did not detect clear differences in the primary outcome (relative risk,RR, 0.85, 95% CI 0.40-1.78, p=0.67) or secondary outcomes, including intubation rate and 28-day mortality. Patients reported prone positioning was comfortable, although almost all patients preferred supine positioning. No adverse events associated with the intervention were observed. Conclusions APP was not associated with benefit, but there was no sign of harm. Continuous monitoring with wearable devices is both feasible and acceptable for patients. In our population, achieving prolonged APP time was challenging despite a dedicated support team, and patients preferred supine positioning. Clinical Trials Registration NCT05083130.