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Awake Proning in COVID-19 Patients With Hypoxemic Respiratory Failure

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04408222
Enrollment
29
Registered
2020-05-29
Start date
2020-04-16
Completion date
2022-03-06
Last updated
2022-03-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronavirus Infection, Oxygen Deficiency

Keywords

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

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.

Interventions

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

Sponsors

Columbia University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Change in SpO2Before proning and 1 hour after initiation of the prone positionSpO2 was measured by peripheral pulse oximetry.

Secondary

MeasureTime frameDescription
Mean Risk Difference in Intubation RatesDuration of hospitalization or up to 1 month from admissionThe mean risk difference in intubation rates for patients with SpO2 ≥95% vs. \<95% 1 hour after initiation of the prone position was assessed.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026