NCT04368000

Prone Positioning in Awake Patients With COVID-19 Requiring Hospitalization

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: University of Utah · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Acute respiratory distress syndrome (ARDS) is a major complication among patients with severe disease. In a report of 138 patients with COVID-19, 20% developed ARDS at a median of 8 days after the onset of symptoms, with 12.3% of patients requiring mechanical ventilation. Efficacious therapies are desperately needed. Supportive care combined with intermittent prone positioning may improve outcomes. Prone positioning (PP) of patients with severe ARDS (when combined with other lung-protective ventilation strategies) is associated with a significant mortality benefit. In addition, PP for \>12 hours in severe ARDS is strongly recommended by clinical practice guidelines. The aim of this study is to compare the outcomes of prone positioning versus usual care positioning in non-intubated patients hospitalized for COVID-19.

Detailed description

In December 2019, an outbreak of a novel coronavirus (SARS-CoV-2) emerged in Wuhan, China and rapidly spread worldwide. The World Health Organization (WHO) declared the outbreak a pandemic on March 11th, 2020. The clinical disease (COVID-19) is mild in 81% of patients, severe disease occurs in 14%, and 5% of cases result in critical illness. The reported overall case fatality rate (CFR) is 2.3% in China, although the CFR varies widely (0.7- 7.2%) between regions. Older age is associate with increased mortality. The reported CFR is 8% among patients 70-79 years old and 15% in those 80 years and older. Multiple therapies have been proposed based on in vitro evidence or anecdotal reports. Although, no high quality clinical trials have demonstrated an effective treatment regimen other than supportive care. Acute respiratory distress syndrome (ARDS) is a major complication among patients with severe disease. In a report of 138 patients with COVID-19, 20% developed ARDS at a median of 8 days after the onset of symptoms, with 12.3% of patients requiring mechanical ventilation. Efficacious therapies are desperately needed. Supportive care combined with intermittent prone positioning may improve outcomes. Prone positioning (PP) of patients with severe ARDS (when combined with other lung-protective ventilation strategies) is associated with a significant mortality benefit. In addition, PP for \>12 hours in severe ARDS is strongly recommended by clinical practice guidelines. Improvements in gas exchange, cardiac output, and clearance of secretions have been demonstrated with PP, and are thought to contribute to the survival benefits. Low quality evidence from case series and retrospective studies in awake, spontaneously breathing patients suggest PP is feasible, improves oxygenation, and may avoid the need for mechanical ventilation. A recent prospective observational study of early PP combined with high-flow nasal cannula or non-invasive mechanical ventilation was well tolerated and may help patients avoid intubation. This study is a single-center non-blinded randomized controlled pragmatic feasibility study comparing the outcomes of prone positioning (intervention) versus usual care (control) in non-intubated patients hospitalized for COVID-19.

Conditions

• Respiratory Failure
• COVID-19

Interventions

Type	Name	Description
BEHAVIORAL	Intermittent prone positioning instructions	Participants will be given instructions to lie in the prone position for a duration of 1-2 hours, every 4 hours while awake.
BEHAVIORAL	Usual care positioning with no instructions	Participants will not be given instructions to lie in the prone position for any duration.

Timeline

• Start date: 2020-04-29
• Primary completion: 2020-08-06
• Completion: 2020-08-06
• First posted: 2020-04-29
• Last updated: 2020-12-03

Locations

1 site across 1 country: United States