Awake Prone Position for Early Hypoxemia in COVID-19
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- COVID-19
- Sponsor
- Boston University
- Enrollment
- 305
- Locations
- 13
- Primary Endpoint
- Change in respiratory status
- Status
- Completed
- Last Updated
- 4 years ago
Overview
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.
Investigators
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
- •Acute issues
- •Deep venous thrombosis treated for less than 2 days
Outcomes
Primary Outcomes
Change in respiratory status
Time Frame: 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 Outcomes
- Length of time participant spends in the supine position(up to 30 days)
- Length of time participant spends standing or walking(up to 30 days)
- Hospital mortality(up to 30 days)
- Length of time participant spends in the prone position(up to 30 days)
- Length of time participant spends lying on side(up to 30 days)
- Length of time participant spends sitting up(up to 30 days)
- Invasive mechanical ventilation(up to 30 days)
- Dyspnea or difficult/labored breathing(up to 30 days)
- Loss of IV access as a consequence of turning in bed(up to 30 days)
- Acute respiratory distress syndrome (ARDS) diagnosis(up to 30 days)
- Discomfort with proning(up to 30 days)
- Length of hospital stay(up to 30 days)