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Purpose

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.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Supportive Care
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Intervention group 		Participants in the intervention arm will receive a text message on their smartphones linking to the Qualtrics intervention website
  • 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
Active Comparator
Usual care group 		Participants in the usual care arm will receive a text message on their smartphone linking to the Qualtrics usual care website
  • 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

More Details

Status
Completed
Sponsor
Boston University

Study Contact

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.