Awake Proning in COVID-19 Patients With Hypoxemic Respiratory Failure

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ClinicalTrials.gov Identifier: NCT04408222

Recruitment Status : Active, not recruiting

First Posted : May 29, 2020

Last Update Posted : May 29, 2020

Sponsor:

Information provided by (Responsible Party):

Sanja Jelic, Columbia University

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
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

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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 :	April 16, 2020
Estimated Primary Completion Date :	April 2021
Estimated Study Completion Date :	May 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Respiratory Failure

Genetic and Rare Diseases Information Center resources: Severe Acute Respiratory Syndrome

U.S. FDA Resources

Groups and Cohorts

Group/Cohort	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 [ Time Frame: 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 [ Time Frame: 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

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Ages Eligible for Study:	18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Consecutive patients with laboratory-confirmed COVID-19 infection who were admitted to the step-down unit at the Columbia University Irving Medical Center in New York between April 6 and 14, 2020 were included. A confirmed case of COVID-19 was defined by a positive result on a reverse transcriptase-polymerase chain reaction (RT-PCR) assay of a specimen collected on a nasopharyngeal swab. Only laboratory-confirmed cases were included.

Criteria

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.

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.

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04408222

Locations

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United States, New York
Columbia University Medical Center
New York, New York, United States, 10032

Sponsors and Collaborators

Columbia University

Investigators

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Principal Investigator:	Sanja Jelic, MD	Columbia University

More Information

Publications:

Guérin C, Reignier J, Richard JC, Beuret P, Gacouin A, Boulain T, Mercier E, Badet M, Mercat A, Baudin O, Clavel M, Chatellier D, Jaber S, Rosselli S, Mancebo J, Sirodot M, Hilbert G, Bengler C, Richecoeur J, Gainnier M, Bayle F, Bourdin G, Leray V, Girard R, Baboi L, Ayzac L; PROSEVA Study Group. Prone positioning in severe acute respiratory distress syndrome. N Engl J Med. 2013 Jun 6;368(23):2159-68. doi: 10.1056/NEJMoa1214103. Epub 2013 May 20.

Gattinoni L, Taccone P, Carlesso E, Marini JJ. Prone position in acute respiratory distress syndrome. Rationale, indications, and limits. Am J Respir Crit Care Med. 2013 Dec 1;188(11):1286-93. doi: 10.1164/rccm.201308-1532CI. Review.

Sun Q, Qiu H, Huang M, Yang Y. Lower mortality of COVID-19 by early recognition and intervention: experience from Jiangsu Province. Ann Intensive Care. 2020 Mar 18;10(1):33. doi: 10.1186/s13613-020-00650-2.

Pérez-Nieto OR, Guerrero-Gutiérrez MA, Deloya-Tomas E, Ñamendys-Silva SA. Prone positioning combined with high-flow nasal cannula in severe noninfectious ARDS. Crit Care. 2020 Mar 23;24(1):114. doi: 10.1186/s13054-020-2821-y.

Ding L, Wang L, Ma W, He H. Efficacy and safety of early prone positioning combined with HFNC or NIV in moderate to severe ARDS: a multi-center prospective cohort study. Crit Care. 2020 Jan 30;24(1):28. doi: 10.1186/s13054-020-2738-5.

https://www1.nyc.gov/site/doh/Covid/Covid-19-data.page; Accessed April 17, 2020.

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Responsible Party:	Sanja Jelic, Associate Professor of Medicine, Columbia University
ClinicalTrials.gov Identifier:	NCT04408222
Other Study ID Numbers:	AAAT0134
First Posted:	May 29, 2020 Key Record Dates
Last Update Posted:	May 29, 2020
Last Verified:	May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	No
Plan Description:	Individual participant data will not be shared owing to privacy protection.

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Studies a U.S. FDA-regulated Drug Product:	No
Studies a U.S. FDA-regulated Device Product:	No

Keywords provided by Sanja Jelic, Columbia University:


Awake Proning COVID-19 SARS-CoV-2

Additional relevant MeSH terms:

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Coronavirus Infections Severe Acute Respiratory Syndrome Respiratory Insufficiency Hypoxia Coronaviridae Infections Nidovirales Infections	RNA Virus Infections Virus Diseases Respiration Disorders Respiratory Tract Diseases Respiratory Tract Infections Signs and Symptoms, Respiratory

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