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Prone Positioning in Awake Patients With COVID-19 Requiring Hospitalization

NCT04368000 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2020-12-03

No results posted yet for this study

Summary

Acute respiratory distress syndrome (ARDS) is a major complication among patients with severe disease. In a report of 138 patients with COVID-19, 20% developed ARDS at a median of 8 days after the onset of symptoms, with 12.3% of patients requiring mechanical ventilation. Efficacious therapies are desperately needed. Supportive care combined with intermittent prone positioning may improve outcomes.

Prone positioning (PP) of patients with severe ARDS (when combined with other lung-protective ventilation strategies) is associated with a significant mortality benefit. In addition, PP for \>12 hours in severe ARDS is strongly recommended by clinical practice guidelines. The aim of this study is to compare the outcomes of prone positioning versus usual care positioning in non-intubated patients hospitalized for COVID-19.

Conditions

Interventions

BEHAVIORAL

Intermittent prone positioning instructions

Participants will be given instructions to lie in the prone position for a duration of 1-2 hours, every 4 hours while awake.

BEHAVIORAL

Usual care positioning with no instructions

Participants will not be given instructions to lie in the prone position for any duration.

Sponsors & Collaborators

Principal Investigators

  • Stacy A Johnson, MD · University of Utah

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-04-29
Primary Completion
2020-08-06
Completion
2020-08-06

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

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 NCT04368000 on ClinicalTrials.gov