Cerebral Blood FlowProBrainNCT05050838
Prone Positioning for Brain-injured Patients With Severe ARDS (ProBrain)
An observational study of Cerebral Blood Flow, run by Fondation Ophtalmologique Adolphe de Rothschild at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 to 95 years
- Conditions the study is for
- Cerebral Blood Flow
- What is being tested?
- Transcranial Doppler (TCD)
- How many people
- 11 participants
- Where
- 1 siteFrance
- Study dates
- 1 Aug 2018to 30 Jun 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 95 years
- No healthy volunteers
- Adult, Older adult
Study population: - Brain-injured patients with ARDS requirering prone positioning
Who may be able to join
- adult's patients suffering from brain injuries
- patients neurologically monitored with TCD
- patients requiring prone position for severe ARDS
Who cannot join
- pregnant women
- patients with contrindication to prone position
Trial locations and contacts
1 site in 1 country.
France1 site
Hôpital Fondation Adolphe de Rothschild
Paris, Île-de-France Region, 75019
About this study
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
- Being tested
- Transcranial Doppler (TCD)
- Keywords
- Prone Position, Acute Respiratory Distress Syndrome, Intracranial Pressure
- Medical subject headings
- Respiratory Distress Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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).
What is being measured
The primary outcome is the main question the study is designed to answer.
Cerebral Blood Flow
Cerebral Blood Flow measurement before and after prone positioning
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2021
- Study start1 Aug 2018
- Primary completion30 Jun 2020
- Study completion30 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral Blood FlowStudies of the same condition, open and under way.
- More trials run by Fondation Ophtalmologique Adolphe de RothschildThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondation Ophtalmologique Adolphe de Rothschild
- Sponsor type
- Research network
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05050838
- Sponsor's protocol ID
- CE_20181218_3_CG
- Acronym
- ProBrain
- Status last verified
- Sep 2021
- First submitted
- 9 Sep 2021
- Last updated
- 21 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prone Positioning for Brain-injured Patients With Severe ARDS (ProBrain)
- ClinicalTrials.gov ID
- NCT05050838
- Acronym / sponsor ID
- ProBrain / CE_20181218_3_CG
- Conditions
- Cerebral Blood Flow
- Keywords
- Prone Position, Acute Respiratory Distress Syndrome, Intracranial Pressure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Fondation Ophtalmologique Adolphe de RothschildResearch network
- Study start
- 1 Aug 2018 (actual)
- Primary completion
- 30 Jun 2020 (actual)
- Study completion
- 30 Jun 2020 (actual)
- First posted
- 21 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 95 years
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- - Brain-injured patients with ARDS requirering prone positioning
Key inclusion criteria (3 listed)
- adult's patients suffering from brain injuries
- patients neurologically monitored with TCD
- patients requiring prone position for severe ARDS
Key exclusion criteria (2 listed)
- pregnant women
- patients with contrindication to prone position
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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). | Other | – |
Primary outcome
Cerebral Blood Flow
Time frame: 1 hour
Cerebral Blood Flow measurement before and after prone positioning
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cerebral Blood Flow, run by Fondation Ophtalmologique Adolphe de Rothschild at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cerebral Blood Flow (time frame: 1 hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2021.