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Completed

NCT Number: NCT04408222

Awake Proning in COVID-19 Patients With Hypoxemic Respiratory Failure

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.

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Key information

Conditions

Oxygen Deficiency COVID-19 Coronaviridae Infections Coronavirus Infection Coronavirus Infections Hypoxia Infections Lung Diseases Nidovirales Infections Pathological Conditions, Signs and Symptoms Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Signs and Symptoms Signs and Symptoms, Respiratory Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Columbia University Irving Medical Center

New York, 10032, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Awake proning

Other

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

Primary outcomes

  1. Change in SpO2

    Time frame: Before proning and 1 hour after initiation of the prone position

    SpO2 was measured by peripheral pulse oximetry.

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Columbia University

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2022
First posted
May 29, 2020
Registry last updated
Mar 9, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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