NCT05130541

Proning Early in Awake COVID-19 Hypoxic Respiratory Failure (PREACHR) Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 219 (actual)
• Sponsor: New York Hospital Queens · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The aim of this proposal is to study whether proning, a technique that has previously been shown to improve lung function in patients with acute respiratory distress syndrome (ARDS), can prevent those with mild to moderate symptoms of COVID-19 from progressing to severe disease when initiated early, thereby averting intubation, reducing hospitalization, and, ultimately, decreasing mortality.

Detailed description

COVID-19 is a global pandemic caused by the novel coronavirus SARS-COV-2. At this time, SARS-CoV-2 is believed to infect alveolar cells, directly impairing lung function and eliciting a profound inflammatory response that further damages the lungs. Between 1 in 20 and 1 in 10 patients infected with this virus die. A crucial decision point in the treatment of patients with COVID-19 in the Emergency Department is the decision to admit to the hospital for further treatment, or discharge the moderately symptomatic (hypoxic and feel ill) but not critically ill patients. However, patients who present with initially mild to moderate symptoms may progress to severe disease. There is, therefore, an unmet need to identify interventions that prevent progression to critical illness in moderately symptomatic patients. Anecdotal reports from Emergency Physicians suggest that alternating prone and supine positioning (i.e. instructing the patient to periodically turn over) improves hypoxia and delays intubation. Dubbed proning, this technique improves hypoxia in 6-7 out of 10 intubated patients with severe acute respiratory distress syndrome (ARDS). Alternating supine and prone positioning improves the recruitment of alveoli, improves ventilation-perfusion matching, increases end-expiratory lung volumes, and improves pulmonary lymphatic drainage. This proposal is innovative because it studies the extension of an intervention previously restricted to patients in the intensive care units with severe acute respiratory distress syndrome (ARDS). Current literature on proning in awake patients with ARDS is limited to retrospective studies with no randomized controlled trials. Further, no clinical trials to date have explored the benefits of early awake proning in COVID-19. The development of a treatment that prevents disease progression and hospitalization in patients moderately ill with COVID-19 would decrease morbidity and mortality from COVID-19 as well as decrease the utilization of scarce healthcare resources. In addition, this trial would be the first randomized controlled-trial, contributing significantly to the nascent evidence base on treatment for COVID-19.

Conditions

• Covid19
• Respiratory Failure

Interventions

Type	Name	Description
BEHAVIORAL	Proning	Rotating on long axis 90 degrees every 30 minutes
OTHER	Supportive Care	Usual Care

Timeline

• Start date: 2020-06-01
• Primary completion: 2021-03-01
• Completion: 2021-05-01
• First posted: 2021-11-23
• Last updated: 2021-11-23

Locations

1 site across 1 country: United States