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Awake Prone Position for Early Hypoxemia in COVID-19

NCT04344587 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 305

Last updated 2021-11-01

No results posted yet for this study

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.

Conditions

Interventions

OTHER

Self-prone position recommendation

The Qualtrics self-prone position recommendation intervention website will include the following sections: 1. Welcome message 2. Educational review of the potential benefits of prone positioning 3. How-To guide to safely "prone" in a hospital bed 4. A recommendation to "prone" while lying in bed (4 times for 1-2 hours each during the day and at night every 24 hours). 5. 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: 1. Welcome message 2. 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

Sponsors & Collaborators

  • Boston University

    lead OTHER

Principal Investigators

  • Allan J Walkey, MD · Boston University

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-04-23
Primary Completion
2021-05-07
Completion
2021-05-07

Countries

  • United States
  • Spain

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04344587 on ClinicalTrials.gov