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OpenTrials
Completed

NCT Number: NCT05050838

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

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.

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Key information

Age range

18 year–95 year

Study type

Observational

Primary location

Hôpital Fondation Adolphe de Rothschild

Paris, Île-de-France Region, 75019, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Transcranial Doppler (TCD)

Other

TCD ultrasonography is based on the principle of the Doppler effect. According to this principle, ultrasound waves emitted from the Doppler probe are transmitted through the skull and reflected by moving red blood cells within the intracerebral vessels. The difference in the frequency between the emitted and reflected waves, referred to as the "Doppler shift frequency," is directly proportional to the speed of the moving red blood cells (blood flow).

Cerebral blood flow (in cm/s) of the middle cerebral artery will be measured with TCD in blood-injured ARDS patients before and one hour after prone positioning (normal ranges: 48 to 72 cm/s).

Primary outcomes

  1. Cerebral Blood Flow

    Time frame: 1 hour

    Cerebral Blood Flow measurement before and after prone positioning

Sponsors and collaborators

Lead sponsor

Fondation Ophtalmologique Adolphe de Rothschild

Network

Registry information

Acronym: ProBrain

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Sep 21, 2021
Registry last updated
Sep 21, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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