Prone Positioning in Awake Patients With COVID-19 Requiring Hospitalization
Stopped early · Not applicable
Conditions studied: Respiratory Failure, COVID-19
In brief
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.
Key facts
- Study ID
- NCT04368000
- Run by
- University of Utah
- People needed
- 30
- Starts
- 2020-04-29
- Expected to finish
- 2020-08-06
- Last updated by the study team
- 2020-12-03
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Adult (age ≥ 18 years)
- Suspected or Confirmed COVID-19 (Suspected: High clinical suspicion AND pending COVID-19 assay; Confirmed: Positive COVID-19 assay within 10 days)
- Scheduled for admission or already admitted to an inpatient hospital bed
- Patients must be enrolled within 48 hours of hospital admission
You may not qualify if…
- Pregnant
- Prisoner
- Contraindication to prone positioning: known increased intracranial pressure >30 mm Hg or cerebral perfusion pressure <60 mm Hg, increased abdominal pressure or risk for abdominal compartment syndrome, massive hemoptysis requiring urgent intervention, tracheal surgery or sternotomy during previous 14 days, facial surgery or serious facial trauma within 14 days, pacemaker implantation within 48 hours, unstable spine, femur, or pelvic fractures, chest tube, mean arterial pressure less than 65 mm Hg
- Lung transplant
- Burns on more than 20% of body surface
- Chronic respiratory failure requiring: mechanical ventilation via endotracheal device (e.g. tracheostomy tube, orotracheal tube, or nasotracheal tube)
- Inability to change position from supine to prone and prone to supine without assistance
- Receiving end of life care, comfort measures only, or hospice
Where it is running
- University of Utah Health Sciences Center — Salt Lake City, Utah, United States
Full record on ClinicalTrials.gov
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