Awake Proning in COVID-19 Patients With Hypoxemic Respiratory Failure

• ClinicalTrials.gov Identifier: NCT04408222
• Recruitment Status: Active, not recruiting
• First Posted: May 29, 2020
• Last Update Posted: May 29, 2020
• Sponsor: Columbia University
• Information provided by (Responsible Party): Sanja Jelic, Columbia University

Tracking Information

• First Submitted Date: May 25, 2020
• First Posted Date: May 29, 2020
• Last Update Posted Date: May 29, 2020
• Actual Study Start Date: April 16, 2020
• Estimated Primary Completion Date: April 2021 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: May 27, 2020)

Change in SpO2 [ Time Frame: Before proning and 1 hour after initiation of the prone position ]

SpO2 was measured by peripheral pulse oximetry.

• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted

Current Secondary Outcome Measures (submitted: May 27, 2020)

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.

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Awake Proning in COVID-19 Patients With Hypoxemic Respiratory Failure
• Official Title: Awake Proning in Patients With COVID-19-Induced Acute Hypoxemic Respiratory Failure
• 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.
• 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 Type: Observational
• Study Design: Observational Model: Cohort; Time Perspective: Retrospective
• Target Follow-Up Duration: Not Provided
• Biospecimen: Not Provided
• 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.

Condition

• Oxygen Deficiency
• Coronavirus Infection

Intervention

Other: Awake proning

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

Study Groups/Cohorts

Awake Proning

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

Intervention: Other: Awake proning

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.

Recruitment Information

• Recruitment Status: Active, not recruiting
• Actual Enrollment (submitted: May 27, 2020): 29
• Original Actual Enrollment: Same as current
• Estimated Study Completion Date: May 2021
• Estimated Primary Completion Date: April 2021 (Final data collection date for primary outcome measure)

Eligibility 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT04408222
• Other Study ID Numbers: AAAT0134
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

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

IPD Sharing Statement

• Plan to Share IPD: No
• Plan Description: Individual participant data will not be shared owing to privacy protection.

• Responsible Party: Sanja Jelic, Columbia University
• Study Sponsor: Columbia University
• Collaborators: Not Provided

Investigators

• Principal Investigator: Sanja Jelic, MD; Columbia University

• PRS Account: Columbia University
• Verification Date: May 2020