Official Title
Awake Prone Position for Early Hypoxemia in COVID-19
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-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.

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 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.

Enrolling by invitation
COVID-19

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
Intervention group

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
Usual care group

Eligibility Criteria

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

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

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years
Countries
Spain
United States
Locations

Long Beach Medical Center - MemorialCare
Long Beach, California, 90806

Alvarado Hospital
San Diego, California, 92120

St. Joseph's Hospital National Jewish Health
Denver, Colorado, 80218

MedStar Georgetown University Hospital
Washington, District of Columbia, 20007

Piedmont Atlanta
Atlanta, Georgia, 30309

University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242

University of Kansas Medical Center
Kansas City, Kansas, 66160

Boston Medical Center
Boston, Massachusetts, 02118

University of Michigan
Ann Arbor, Michigan, 48109

Creighton University
Omaha, Nebraska, 68178

Michael E. DeBakey Veteran Affairs Medical Center
Houston, Texas, 77030

VCU Medical Center
Richmond, Virginia, 23219

Allan J Walkey, MD
Study Director
Boston University

Boston University
NCT Number
Keywords
Prone position
Coronavirus
Inhalation oxygen therapy
Pragmatic Clinical Tria
Hypoxia
MeSH Terms
Hypoxia