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.
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 controlled unblinded trial. The study compares a smartphone tool that
recommends 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) to usual care.
Participants who are assigned to the intervention arm will receive a text message containing
a link to an online website that reviews how to safely self-prone position and a
recommendation to self-prone position 4 times for 1-2 hours each during the day and at night
every 24 hours. Participants will also receive twice daily reminders to self-prone using the
same smartphone platform.
All participants will receive twice daily Qualtrics online surveys to answer questions about
which body positions they used in bed and their level of comfort and shortness of breath.
Participants will receive these twice daily text messages until they are discharged, until
they are transferred to the ICU, until they die, until their lung function declines, or until
14 days pass since enrollment. Thus, most participants will receive twice daily text messages
for about 1 week; it is expected that almost all patients will receive twice daily text
messages for no longer than 14 days. Medical charts will be reviewed daily to track routine
clinical data to determine outcomes.
Boston Medical Center (BMC) / Boston University will be one of the 16 sites and the data
coordinating center for this multisite trial. The unique design of the study means that if
evidence accumulates that one treatment is better than the other, more participants will be
chosen to receive the prone position intervention that works over time. Thus, the trial will
both show what works, implement what works, and make sure that the most participants receive
the treatment that works.
Other: Self-prone position recommendation
The Qualtrics self-prone position recommendation intervention website will include the following sections:
Welcome message
Educational review of the potential benefits of prone positioning
How-To guide to safely "prone" in a hospital bed
A recommendation to "prone" while lying in bed (4 times for 1-2 hours each during the day and at night every 24 hours).
A reminder to keep track of the time spent in 1) prone position, 2) lying flat on back, 3) lying on side, 4) sitting up, and 5) standing or walking
Other: Usual care
The Qualtrics usual care website will include the following sections:
Welcome message
A reminder to keep track of the time spent in 1) prone position, 2) lying flat on back, 3) lying on side, 4) sitting up, and 5) standing or walking
Inclusion Criteria:
- 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 Criteria:
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
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, 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
Allan J Walkey, MD, Study Director
Boston University