Awake Prone Position for Early Hypoxemia in COVID-19
- Conditions
- COVID-19
- Interventions
- Other: Usual careOther: Self-prone position recommendation
- Registration Number
- NCT04344587
- Lead Sponsor
- Boston University
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 305
- 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
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Usual care group Usual care Participants in the usual care arm will receive a text message on their smartphone linking to the Qualtrics usual care website Intervention group Self-prone position recommendation Participants in the intervention arm will receive a text message on their smartphones linking to the Qualtrics intervention website
- Primary Outcome Measures
Name Time Method Change in respiratory status up to 30 days Change in respiratory status will be defined as:1) admission to the ICU and/or a 2) an increase in supplemental oxygen delivery (defined as an increase in oxygen delivery rate of ≥2 liter per minute compared to the oxygen delivery rate at the time of intervention or usual care text message that is sustained for ≥12 or more hours OR the switch to an oxygen delivery method that increases the level of supplemental oxygen.
- Secondary Outcome Measures
Name Time Method Hospital mortality up to 30 days Hospital mortality will be abstracted from the electronic medical record
Length of time participant spends in the supine position up to 30 days Length of time in the supine/lying on back position will be assessed from the smartphone survey and measured in categories of no time, up to 6 hours, 6 hours to 11 hours, 12 hours or more.
Length of time participant spends standing or walking up to 30 days Length of time standing or walking will be assessed from the smartphone survey and measured in categories of no time, up to 6 hours, 6 hours to 11 hours, 12 hours or more.
Length of time participant spends in the prone position up to 30 days Length of time in the prone position will be assessed from the smartphone survey and measured in categories of no time, up to 6 hours, 6 hours to 11 hours, 12 hours or more.
Length of time participant spends lying on side up to 30 days Length of time lying on side will be assessed from the smartphone survey and measured in categories of no time, up to 6 hours, 6 hours to 11 hours, 12 hours or more.
Length of time participant spends sitting up up to 30 days Length of time sitting up will be assessed from the smartphone survey and measured in categories of no time, up to 6 hours, 6 hours to 11 hours, 12 hours or more.
Invasive mechanical ventilation up to 30 days Invasive mechanical ventilation will be abstracted from the electronic medical record.
Dyspnea or difficult/labored breathing up to 30 days Dyspnea will be assessed by the modified Borg Dyspnea Score (10-point ordinal scale) from 1= nothing at all to 10= maximal. Higher scores indicate more dyspnea.
Loss of IV access as a consequence of turning in bed up to 30 days Loss of IV access as a consequence of turning in bed will be reported by participant using monitoring surveys
Acute respiratory distress syndrome (ARDS) diagnosis up to 30 days ARDS diagnosis will be abstracted from the electronic medical record
Discomfort with proning up to 30 days Discomfort with proning (4-point ordinal scale: very comfortable, somewhat comfortable, somewhat uncomfortable, very uncomfortable)
Length of hospital stay up to 30 days Total number of days hospitalized will be abstracted from the electronic medical record.
Trial Locations
- Locations (13)
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
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
University of Kansas Medical Center
🇺🇸Kansas City, Kansas, United States