Smartphone-Guided Self-prone Positioning vs Usual Care in Nonintubated Hospital Ward Patients With COVID-19: A Pragmatic Randomized Clinical Trial

Garrett Rampon, Shijing Jia, Ritwick Agrawal, Nicholas Arnold, Alejandro Martín-Quirόs, Ernest A. Fischer, James Malatack, Nikhil Jagan, Amen Sergew, Amy Hajari Case, Kristin Miller, Maged Tanios, Gheorghe Doros, Craig S. Ross, Michael A. Garcia, Kari R. Gillmeyer, Nicholas G. Griffiths, Badr Jandali, Katherine L. Modzelewski, Justin M. RucciSteven Q. Simpson, Allan J. Walkey, Nicholas A. Bosch

Research output: Contribution to journalArticlepeer-review

1 Scopus citations

Abstract

Background: Safe, effective, and easily implementable treatments that reduce the progression of respiratory failure in COVID-19 are urgently needed. Despite the increased adoption of prone positioning during the pandemic, the effectiveness of this technique on progression of respiratory failure among nonintubated patients is unclear. Research Question: What is the effectiveness of smartphone-guided self-prone positioning recommendations and instructions compared with usual care in reducing progression of respiratory failure among nonintubated patients with COVID-19? Study Design and Methods: Awake Prone Position for Early Hypoxemia in COVID-19 (APPEX-19) is a multicenter randomized clinical trial that randomized nonintubated adults with COVID-19 on < 6 L/min of supplemental oxygen to receive a smartphone-guided self-prone positioning intervention or usual care. The primary outcome was the composite of respiratory deterioration (an increase in supplemental oxygen requirement) or ICU transfer. Using a Bayesian statistical approach, the posterior probability of superiority within each treatment arm (superiority threshold 95%) was calculated. Results: The trial was stopped early for slow enrollment. A total of 293 participants were included in the modified intention-to-treat analysis (159 self-prone positioning intervention and 134 usual care). Among participants who self-reported body positioning (n = 139 [70 intervention, 69 usual care]), 71.4% in the intervention arm and 59.4% in the usual care arm attempted prone positioning. Thirty-one participants (posterior mean, 24.7%; 95% credible interval, 18.6-31.4) receiving usual care and 32 participants (posterior mean, 22.1%; 95% credible interval, 16.6-28.1) receiving the self-prone positioning intervention experienced the primary outcome; the posterior probability of superiority for the self-prone positioning intervention was 72.1%, less than the 95% threshold for superiority. Adverse events occurred in 26.9% of participants in the usual care arm and in 11.9% of participants in the intervention arm. Interpretation: Among nonintubated patients with COVID-19, smartphone-guided self-prone positioning recommendations and instructions did not promote strong adherence to prone positioning. Clinical Trial Registration: ClinicalTrials.gov; No.: NCT04344587; URL: www.clinicaltrials.gov.

Original languageEnglish (US)
Pages (from-to)782-791
Number of pages10
JournalChest
Volume162
Issue number4
DOIs
StatePublished - Oct 2022

All Science Journal Classification (ASJC) codes

  • Pulmonary and Respiratory Medicine
  • Critical Care and Intensive Care Medicine
  • Cardiology and Cardiovascular Medicine

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