Awake Prone Positioning for COVID-19 Acute Hypoxaemic Respiratory Failure

May 17, 2023 updated by: Younes Oujidi, Mohammed VI University Hospital

Awake Prone Positioning for COVID-19 Acute Hypoxaemic Respiratory Failure: Retrospective Cohort Study

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

1069

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Morocco
      • Oujda, Morocco, 60000
        • Amine Elmouhib

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Each awake 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.

Epidemiological, clinical, paraclinical, therapeutic and evolutionary data were collected using a data processing form including the different variables collected in the patients' medical records. These data were then computerized and analyzed using IBM SPSS version 21 software.

Qualitative variables were described as numbers and/or percentages, and quantitative variables as mean ± standard deviation, or as median with interquartile range for variables not having a normal distribution.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluate the effectiveness of awake prone position in preventing intubation or death in spontaneously ventilated patients with COVID-19 with acute respiratory failure.
Time Frame: 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.
22 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
length of stay in intensive care unit, length of time from hospitalization to death, length of time from hospitalization to intubation.
Time Frame: 22 months
length of stay in intensive care unit, length of time from hospitalization to death, length of time from hospitalization to intubation.
22 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mohammed VI University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2020

Primary Completion (Actual)

December 28, 2021

Study Completion (Actual)

December 30, 2021

Study Registration Dates

First Submitted

March 27, 2023

First Submitted That Met QC Criteria

May 17, 2023

First Posted (Actual)

May 19, 2023

Study Record Updates

Last Update Posted (Actual)

May 19, 2023

Last Update Submitted That Met QC Criteria

May 17, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • unit critical care

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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