Effect of Prone Positionning in Non Intubated Patients

July 22, 2024 updated by: Mhamed Sami Mebazaa, Mongi Slim Hospital

Prone Positionning in Non Intubated ICU Patients With SARS-COV2

Retrospective single center study on the effect of awake prone positioning in ICU patients with severe hypoxemia related to SARS-COV2

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Retrospective, observational study on the effects of awake prone positioning on oxygenation, invasive mechanical ventilation requirement and mortality in non intubation patients with severe hypoxemia related to SARS-COV2 and regardeless of the oxygen supplementation method.

Study Type

Observational

Enrollment (Actual)

114

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

  • Tunisia
      • Tunis, Tunisia, 2046
        • Mongi Slim Hospital

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

No

Sampling Method

Non-Probability Sample

Study Population

All adult (> 18 years) patients admitted in the ICU:

  • with acute respiratory failure due to COVID-19 pulmonary infection
  • non intubated
  • regardeless of the exygenation method: HFONC, face mask, non invasive ventilation

Description

Inclusion Criteria:

  • All adult (> 18 years) patients, non intubated, with acute respiratory failure due to COVID-19 pulmonary infection

Exclusion Criteria:

  • patients: hemodynamic instability and high doses of vasopressors
  • patients with contraindications of prone positioning: pregnancy, recent abdominal surgery
  • patients with pulmonay embolism
  • patients requiring invasive mechanical ventilation for extra respiratory reasons: neurological failure, urgent surgery

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
Prone position group
Prone positioning sessions: at least 1 session per day session duration: at least 2 hours
Procedure: Prone positioning
Prone positioning sessions: at least one session per day proning duration: 2 hours at least per session
Control group
no prone positioning

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intubation
Time Frame: at day 7
invasive mechanical ventilation requirement
at day 7
Intubation
Time Frame: at day 14
invasive mechanical ventilation requirement
at day 14

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ICU mortality
Time Frame: at Day 14
observed mortality rate in the ICU
at Day 14

Collaborators and Investigators

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

Sponsor

Mongi Slim Hospital

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)

January 1, 2021

Primary Completion (Actual)

September 30, 2021

Study Completion (Actual)

October 30, 2021

Study Registration Dates

First Submitted

July 22, 2024

First Submitted That Met QC Criteria

July 22, 2024

First Posted (Actual)

July 24, 2024

Study Record Updates

Last Update Posted (Actual)

July 24, 2024

Last Update Submitted That Met QC Criteria

July 22, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • COVID PP

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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