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Awake Proning in COVID-19 Patients With Hypoxemic Respiratory Failure

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

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 *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
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
Removed Location Countries  
 
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