Awake Proning in COVID-19 Patients With Hypoxemic Respiratory Failure

NCT ID: NCT04408222

Last Updated: 2022-03-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

29 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-04-16

Study Completion Date

2022-03-06

Brief Summary

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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

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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.

Conditions

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Oxygen Deficiency Coronavirus Infection

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Awake Proning

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

Awake proning

Intervention Type OTHER

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

Interventions

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Awake proning

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Columbia University

OTHER

Sponsor Role lead

Responsible Party

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Sanja Jelic

Associate Professor of Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sanja Jelic, MD

Role: PRINCIPAL_INVESTIGATOR

Columbia University

Locations

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Columbia University Irving Medical Center

New York, New York, United States

Site Status

Countries

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United States

References

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Guerin 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.

Reference Type BACKGROUND
PMID: 23688302 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24134414 (View on PubMed)

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. No abstract available.

Reference Type BACKGROUND
PMID: 32189136 (View on PubMed)

Perez-Nieto OR, Guerrero-Gutierrez MA, Deloya-Tomas E, Namendys-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. No abstract available.

Reference Type BACKGROUND
PMID: 32204726 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32000806 (View on PubMed)

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

Reference Type BACKGROUND

Other Identifiers

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AAAT0134

Identifier Type: -

Identifier Source: org_study_id

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