Awake Proning in COVID-19 Patients With Hypoxemic Respiratory Failure

NCT04408222 | Completed

• 1 other identifier: AAAT0134
• Study Type: observational
• Target: 29
• Locations: 1 country
• Sites: 1

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.

Conditions

Oxygen Deficiency; Coronavirus Infection

Keywords

Awake Proning; COVID-19; SARS-CoV-2

Outcome Measures

Primary Outcomes (1)

• Change in SpO2

  SpO2 was measured by peripheral pulse oximetry.

  Before proning and 1 hour after initiation of the prone position

Secondary Outcomes (1)

• Mean Risk Difference in Intubation Rates

  Duration of hospitalization or up to 1 month from admission

Study Arms (1)

Awake Proning

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

Other: Awake proning

Interventions

Awake proning OTHER

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

Awake Proning

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• Altered mental status with inability to turn in bed without assistance

Sponsors & Collaborators

• Columbia University: lead

Study Sites (1)

Columbia University Irving Medical Center

New York, New York, 10032, United States

Location

Related Publications (6)

• 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.

  PMID: 23688302 BACKGROUND

• 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.

  PMID: 24134414 BACKGROUND

• 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.

  PMID: 32189136 BACKGROUND

• 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.

  PMID: 32204726 BACKGROUND

• 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.

  PMID: 32000806 BACKGROUND

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

  BACKGROUND

MeSH Terms

Conditions

Hypoxia; Coronavirus Infections; COVID-19

Condition Hierarchy (Ancestors)

Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Sanja Jelic, MD

  Columbia University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine

Study Record Dates

• First Submitted: May 25, 2020
• First Posted: May 29, 2020
• Study Start: April 16, 2020
• Primary Completion: April 16, 2021
• Study Completion: March 6, 2022
• Last Updated: March 9, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)