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.
Keywords: COVID-19; awake prone position; low- middle- income country; randomised controlled trial.
Lying on ones front (prone) can have beneficial effects for the lungs in very sick patients on ventilators. In people not on ventilators, but nevertheless requiring breathing assistance through oxygen devices, it is less clear whether this position is still beneficial. There have been several studies in patients with COVID-19 examining this, but results differ between studies. Very few studies have been carried out in patients who have been vaccinated against COVID-19, or in low and middle income countries. We carried out a study in Vietnam, a lower-middle income country to examine this. In total 93 patients participated in the study and were randomly treated following standard care (verbal advice to change positions) or were provided with a special team present in the ward to help them and encourage them to lie in a prone position for as long as possible every day. The rate of patients requiring next level of support for breathing was compared between groups. Our results showed that there was no difference between treatment groups in the rate of patients requiring extra breathing support, or in mortality rates, although some indication of shorter hospitalization times in those lying prone. Participants reported that they found lying prone comfortable, however most still preferred to lie on their back.
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