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NCT05050838 Clinical Trial

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

Cerebral Blood Flow Clinical Trial

— ProBrain  

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05050838
Other study ID # CE_20181218_3_CG
Secondary ID
Status Completed
Phase
First received
Last updated
Start date August 1, 2018
Est. completion date June 30, 2020

Study information
Verified date September 2021
Source Fondation Ophtalmologique Adolphe de Rothschild
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Completed
Enrollment 11
Est. completion date June 30, 2020
Est. primary completion date June 30, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years to 95 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Other:
• Transcranial Doppler (TCD)
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).

Locations
Country Name City State
France Hôpital Fondation Adolphe de Rothschild Paris Ile-de-France

Sponsors (1)
Lead Sponsor Collaborator
Fondation Ophtalmologique Adolphe de Rothschild

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Cerebral Blood Flow Cerebral Blood Flow measurement before and after prone positioning 1 hour
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