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

NCT05050838 | Completed

• 1 other identifier: CE_20181218_3_CG
• Study Type: observational
• Target: 11
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cerebral Blood Flow

Keywords

Prone Position; Acute Respiratory Distress Syndrome; Intracranial Pressure

Outcome Measures

Primary Outcomes (1)

• Cerebral Blood Flow

  Cerebral Blood Flow measurement before and after prone positioning

  1 hour

Interventions

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).

Eligibility Criteria

• Age: 18 Years - 95 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

\- Brain-injured patients with ARDS requirering prone positioning

You may qualify if:

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

You may not qualify if:

• pregnant women
• patients with contrindication to prone position

Sponsors & Collaborators

• Fondation Ophtalmologique Adolphe de Rothschild: lead

Study Sites (1)

Hôpital Fondation Adolphe de Rothschild

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

Location

MeSH Terms

Conditions

Respiratory Distress Syndrome

Interventions

Ultrasonography, Doppler, Transcranial

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders

Intervention Hierarchy (Ancestors)

Echoencephalography; Neuroradiography; Neuroimaging; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Radiography; Ultrasonography; Ultrasonography, Doppler; Diagnostic Techniques, Neurological; Investigative Techniques

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 9, 2021
• First Posted: September 21, 2021
• Study Start: August 1, 2018
• Primary Completion: June 30, 2020
• Study Completion: June 30, 2020
• Last Updated: September 21, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)