Awake Prone Position for Early Hypoxemia in COVID-19
Completed · Not applicable
Conditions studied: COVID-19
In brief
Prone positioning is a well studied and validated treatment for severe acute respiratory distress syndrome (ARDS), however there are no randomized studies on the use of prone positioning in the non-intubated patient. It is unknown if this intervention would be helpful in preventing further respiratory deterioration in terms of increasing supplemental oxygen requirements, endotracheal intubation, and ICU admission. The Awake Prone Position for Early hypoxemia in COVID-19 (APPEX-19) Study is a pragmatic adaptive randomized controlled unblinded trial. APPEX-19 randomizes non-ICU patients with COVID-19 or who are under evaluation for COVID-19 to lie in a prone position (i.e, with their stomach and chest facing down) or to usual care.
Key facts
- Study ID
- NCT04344587
- Run by
- Boston University
- People needed
- 305
- Starts
- 2020-04-23
- Expected to finish
- 2021-05-07
- Last updated by the study team
- 2021-11-01
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Assigned to or admitted to a COVID-19 ward team at a participating site (these teams only admit patients who are under investigation for COVID-19 or who have confirmed COVID-19 infection) via the emergency department (ED) within the last 24 hours
- Have access to their own functioning smartphone in the hospital room
- English or Spanish-speaking
- Ability to read simple instructions and answer simple written questions
You may not qualify if…
- Baseline patient factors
- Inability to operate the hospital bed
- Inability to lie flat comfortably
- Inability to lie flat without shortness of breath
- Inability to turn over independently
- Medical comorbidities
- Hemoptysis in the last 2 days
- Prior lung transplant
- Dementia
- Acute issues
- Deep venous thrombosis treated for less than 2 days
- Unstable spine, femur, or pelvic fractures
- Mean arterial pressure lower than 65 mmHg
- Receiving ≥6 liters per minute of supplemental oxygen via nasal cannula, nasal pendant, or shovel mask
- Receiving supplemental oxygen via more aggressive methods (e.g. Venturi mask or non-rebreather mask)
- Recent interventions
- Chest tube in place
- Tracheal surgery or sternotomy during the previous 15 days
- Serious facial trauma or facial surgery during the previous 15 days
- Cardiac pacemaker inserted in the last 2 days
- Other
- Pregnancy
- Comfort measures only status
- Prisoner
Where it is running
- Long Beach Medical Center - MemorialCare — Long Beach, California, United States
- Alvarado Hospital — San Diego, California, United States
- St. Joseph's Hospital National Jewish Health — Denver, Colorado, United States
- MedStar Georgetown University Hospital — Washington D.C., District of Columbia, United States
- Piedmont Atlanta — Atlanta, Georgia, United States
- University of Iowa Hospitals and Clinics — Iowa City, Iowa, United States
- University of Kansas Medical Center — Kansas City, Kansas, United States
- Boston Medical Center — Boston, Massachusetts, United States
- University of Michigan — Ann Arbor, Michigan, United States
- Creighton University — Omaha, Nebraska, United States
- Michael E. DeBakey Veteran Affairs Medical Center — Houston, Texas, United States
- VCU Medical Center — Richmond, Virginia, United States
- Hospital Universitario La Paz — Madrid, Spain
Full record on ClinicalTrials.gov
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