Awake Prone Positioning for COVID-19 Acute Hypoxaemic Respiratory Failure

Sponsor
Mohammed VI University Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT05866289
Collaborator
(none)
1,069
1
22
48.6

Study Details

Study Description

Brief Summary

The objective of our study is to evaluate the effectiveness of prone position in preventing intubation or death in spontaneously ventilated patients with COVID-19 with acute respiratory failure.

Condition or Disease Intervention/Treatment Phase
  • Other: Prone position

Detailed Description

The COVID-19 pandemic has challenged the management of hypoxemic respiratory failure as limited ICU capacity is strained by a new high-mortality disease and large numbers of patients requiring prolonged periods of hospitalization, as well as respiratory support equipment such as ventilators and intensive care unit (ICU) beds.

If early and prolonged prone positioning (DV) reduces mortality in invasively ventilated patients with acute respiratory distress syndrome (ARDS), its role in conscious patients (DV vigil) remains a subject of debate and research.

This is a retrospective, monocentric, descriptive and analytical cohort conducted over a period of 22 months from March 2020 to December 2021 and involving 1069 patients hospitalized in the intensive care unit of the CHU Mohammed VI of Oujda for the management of acute respiratory failure caused by COVID-19.

Study Design

Study Type:
Observational [Patient Registry]
Actual Enrollment :
1069 participants
Observational Model:
Cohort
Time Perspective:
Other
Official Title:
Awake Prone Positioning for COVID-19 Acute Hypoxaemic Respiratory Failure: Retrospective Cohort Study
Actual Study Start Date :
Mar 1, 2020
Actual Primary Completion Date :
Dec 28, 2021
Actual Study Completion Date :
Dec 30, 2021

Arms and Interventions

Arm Intervention/Treatment
Includes 681 patients who were placed in prone position

Other: Prone position
Each prone position session had a minimum duration of one hour and a maximum duration of 12 hours for a minimum of 3 hours per day.

Includes 388 patients who were placed in supine position

Outcome Measures

Primary Outcome Measures

  1. Evaluate the effectiveness of awake prone position in preventing intubation or death in spontaneously ventilated patients with COVID-19 with acute respiratory failure. [22 months]

    Evaluate the effectiveness of awake prone position in preventing intubation or death in spontaneously ventilated patients with COVID-19 with acute respiratory failure.

Secondary Outcome Measures

  1. length of stay in intensive care unit, length of time from hospitalization to death, length of time from hospitalization to intubation. [22 months]

    length of stay in intensive care unit, length of time from hospitalization to death, length of time from hospitalization to intubation.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • all patients (1069 patients) with ARDS due to SARS-cov2, confirmed by nasopharyngeal swab, who were hospitalized in the COVID-19 ICU from March 1, 2020 to December 31, 2021
Exclusion Criteria:
  • Patients with negative CRP

  • Younger than 18 years of age

  • Patients who died or intubated on the day of admission

  • Patients presented a contraindication

Contacts and Locations

Locations

Site City State Country Postal Code
1 Amine Elmouhib Oujda Morocco 60000

Sponsors and Collaborators

  • Mohammed VI University Hospital

Investigators

None specified.

Study Documents (Full-Text)

More Information

Publications

Responsible Party:
Younes Oujidi, Medical doctor, Mohammed VI University Hospital
ClinicalTrials.gov Identifier:
NCT05866289
Other Study ID Numbers:
  • unit critical care
First Posted:
May 19, 2023
Last Update Posted:
May 19, 2023
Last Verified:
May 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Younes Oujidi, Medical doctor, Mohammed VI University Hospital
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 19, 2023