Awake Proning in COVID-19 Patients With Hypoxemic Respiratory Failure

Completed

• Conditions: Coronavirus Infection; Oxygen Deficiency
• Interventions: Other: Awake proning

• Registration Number: NCT04408222
• Lead Sponsor: Columbia University

Brief Summary

The purpose of this study is to retrospectively review clinical data to determine whether awake proning improves oxygenation in spontaneously breathing patients with COVID-19 severe hypoxemic respiratory failure.

Detailed Description

Critically ill patients with coronavirus disease 2019 (COVID-19) severely strained intensive care resources in New York in April 2020. The prone position improves oxygenation in intubated patients with acute respiratory distress syndrome. The investigators wanted to study whether the prone position is associated with improved oxygenation and decreased risk for intubation in spontaneously breathing patients with severe COVID-19 hypoxemic respiratory failure. Awake prone positioning was implemented based on the health care provider decision.

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study Start: 2020-04-16
• Study First Submitted: 2020-05-25
• Study First Submitted QC: 2020-05-27
• Study First Posted: 2020-05-29
• Primary Completion: 2021-04-16
• Status Verified: 2022-03
• Study Completion: 2022-03-06
• Last Update Submitted: 2022-03-07
• Last Update Posted: 2022-03-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 29

Inclusion Criteria

• Consecutive patients admitted to the Columbia University step-down unit from April 6, 2020.
• Laboratory confirmed COVID-19 infection with severe hypoxemic respiratory failure defined as respiratory rate ≥30 breaths/min and oxyhemoglobin saturation (SpO2) ≤93% while receiving supplemental oxygen 6 L/min via nasal cannula and 15 L/min via non-rebreather facemask.

Read More

Exclusion Criteria

• Altered mental status with inability to turn in bed without assistance
• Extreme respiratory distress requiring immediate intubation, or oxygen requirements less than specified in the inclusion criteria.

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Awake Proning	Awake proning	COVID-19 patients with hypoxemic respiratory failure with awake prone positioning, as tolerated, up to 24 hours daily.

Primary Outcome Measures

Name	Time	Method
Change in SpO2	Before proning and 1 hour after initiation of the prone position	SpO2 was measured by peripheral pulse oximetry.

Secondary Outcome Measures

Name	Time	Method
Mean Risk Difference in Intubation Rates	Duration of hospitalization or up to 1 month from admission	The mean risk difference in intubation rates for patients with SpO2 ≥95% vs. \<95% 1 hour after initiation of the prone position was assessed.

Trial Locations

Locations (1)

Columbia University Irving Medical Center; 🇺🇸 New York, New York, United States