Awake Proning in COVID-19 Patients With Hypoxemic Respiratory Failure

Coronavirus Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04408222
• Other study ID #: AAAT0134
• Status: Completed
• Start date: April 16, 2020
• Est. completion date: March 6, 2022

Study information

• Verified date: March 2022
• Source: Columbia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 29
• Est. completion date: March 6, 2022
• Est. primary completion date: April 16, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Coronavirus Infection
• Coronavirus Infections
• COVID-19
• Hypoxia
• Oxygen Deficiency
• Respiratory Insufficiency

Intervention

Other:
• Awake proning
Prone positioning of awake, as tolerated, for up to 24 hours daily.

Locations

Country	Name	City	State
United States	Columbia University Irving Medical Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Columbia University

Country where clinical trial is conducted

United States, 

References & Publications (6)

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. — View Citation

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. — View Citation

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. — View Citation

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

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in SpO2	SpO2 was measured by peripheral pulse oximetry.	Before proning and 1 hour after initiation of the prone position
Secondary	Mean Risk Difference in Intubation Rates	The mean risk difference in intubation rates for patients with SpO2 =95% vs. <95% 1 hour after initiation of the prone position was assessed.	Duration of hospitalization or up to 1 month from admission