Awake Proning in COVID-19 Patients With Hypoxemic Respiratory Failure

Sponsor

Columbia University (Other)

Overall Status

Completed

CT.gov ID

NCT04408222

Collaborator

(none)

Enrollment

Location

22.6

Actual Duration (Months)

1.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Oxygen Deficiency Coronavirus Infection	Other: Awake proning

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.

Study Design

Study Type:

Observational

Actual Enrollment :

29 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

Awake Proning in Patients With COVID-19-Induced Acute Hypoxemic Respiratory Failure

Actual Study Start Date :

Apr 16, 2020

Actual Primary Completion Date :

Apr 16, 2021

Actual Study Completion Date :

Mar 6, 2022

Arms and Interventions

Arm	Intervention/Treatment
Awake Proning COVID-19 patients with hypoxemic respiratory failure with awake prone positioning, as tolerated, up to 24 hours daily.	Other: Awake proning Prone positioning of awake, as tolerated, for up to 24 hours daily.

Arm

Intervention/Treatment

Awake Proning

COVID-19 patients with hypoxemic respiratory failure with awake prone positioning, as tolerated, up to 24 hours daily.

Other: Awake proning

Prone positioning of awake, as tolerated, for up to 24 hours daily.

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Consecutive patients admitted to the Columbia University step-down unit from April 6,

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.

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.