Status:
COMPLETED
Awake Prone Position for Early Hypoxemia in COVID-19
Lead Sponsor:
Boston University
Conditions:
COVID-19
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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-in...
Detailed Description
The purpose of this multi-site trial is to investigate the use of prone positioning in SARS-CoV-2 infected patients who are not intubated. The APPEX-19 study is a pragmatic adaptive randomized control...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
April 23 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 7 2021
Estimated Enrollment :
305 Patients enrolled
Trial Details
Trial ID
NCT04344587
Start Date
April 23 2020
End Date
May 7 2021
Last Update
November 1 2021
Active Locations (13)
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1
Long Beach Medical Center - MemorialCare
Long Beach, California, United States, 90806
2
Alvarado Hospital
San Diego, California, United States, 92120
3
St. Joseph's Hospital National Jewish Health
Denver, Colorado, United States, 80218
4
MedStar Georgetown University Hospital
Washington D.C., District of Columbia, United States, 20007