Prone Positioning for Brain-injured Patients With Severe ARDS (ProBrain) (ProBrain)

September 10, 2021 updated by: Fondation Ophtalmologique Adolphe de Rothschild
Prone position (PP) is a key component to treat hypoxemia in patients with severe acute respiratory distress syndrome (ARDS). However, most studies evaluating PP effects in patients with ARDS exclude those with brain-injuries without providing any medical evidence. This prospectice observational study aimed to investigate if prone positioning leads to significant modification of cerebral perfusion in brain-injured patients with ARDS.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

11

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

  • France
    • Ile-de-France
      • Paris, Ile-de-France, France, 75019
        • Hôpital Fondation Adolphe de Rothschild

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

18 years to 95 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

- Brain-injured patients with ARDS requirering prone positioning

Description

Inclusion Criteria:

  • adult's patients suffering from brain injuries
  • patients neurologically monitored with TCD
  • patients requiring prone position for severe ARDS

Exclusion Criteria:

  • pregnant women
  • patients with contrindication to prone position

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cerebral Blood Flow
Time Frame: 1 hour
Cerebral Blood Flow measurement before and after prone positioning
1 hour

Collaborators and Investigators

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

Sponsor

Fondation Ophtalmologique Adolphe de Rothschild

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)

August 1, 2018

Primary Completion (ACTUAL)

June 30, 2020

Study Completion (ACTUAL)

June 30, 2020

Study Registration Dates

First Submitted

September 9, 2021

First Submitted That Met QC Criteria

September 10, 2021

First Posted (ACTUAL)

September 21, 2021

Study Record Updates

Last Update Posted (ACTUAL)

September 21, 2021

Last Update Submitted That Met QC Criteria

September 10, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • CE_20181218_3_CG

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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