Traumatic Brain InjuryPULSATILITYNCT02832908
Evaluation of the Physiopathological Phenomena and the Haemodynamic and Cerebral Metabolic Effects From Semi-seated Position to Lying Position in Patients With Brain Trauma
A study testing Change from semi-seated position to supine in people with Traumatic Brain Injury, run by University Hospital, Montpellier at 1 site in France.
Trial summary
Brain trauma is an important burden in traumatologic intensive care. In these patients the treatment is guided by a cluster of multimodal monitoring parameters. Despite this it is difficult to assess the actual physiopathologic status of the brain. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Traumatic Brain Injury
- What is being tested?
- Change from semi-seated position to supine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteFrance
- Study dates
- Dec 2014to Dec 2016
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients with a severe head trauma estimated by the Glasgow Coma Scale and by the Glasgow Outcome Scale
- age > 18
Who cannot join
- Other neurological pathology
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Hôpital Lapeyronie - Département Anesthésie Réanimation A
Montpellier, 34295
Jean Paul ROUSTAN, MD, 04 67 33 82 56, jp-roustan@chu-montpellier.fr
Jean Paul ROUSTAN, MD, phone 0467338256
About this study
Brain trauma is an important burden in traumatologic intensive care. In these patients the treatment is guided by a cluster of multimodal monitoring parameters. Despite this it is difficult to assess the actual physiopathologic status of the brain. Changing the position of these patients (semi-seated to lying position) causes changes in the hémodynamics brain conditions, so in monitoring parameters . The analysis of these changes can givr us valuable clinically informations.
Read the detailed description
Severe brain trauma (CGS < 8 ) are included. PIC, PA, PVC, EKG, airway pressure, SjO2 and NIRSS are continuously monitored.
The patients are in semi seated (30°) position. Once a day they are in supine (0°) for 30 minutes. We record every parameters before and at the end of this supine period.
After time domain and frequency domain signal processing, this parameters are compared to deduct clinical relevant conclusions.
- Conditions
- Traumatic Brain Injury
- Being tested
- Change from semi-seated position to supine
- Medical subject headings
- Brain Injuries, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Change from semi-seated position to supineOther
from semi-seated position (30°) to lying position
| Study group | Role | What they receive |
|---|---|---|
| Patients + parents | Other | Patients with severe head trauma Receives: Other: Change from semi-seated position to supine |
What is being measured
The primary outcome is the main question the study is designed to answer.
ASSESSMENT OF THE CEREBRAL OXYGENATION
Measured: UP TO 6 MONTHS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2016 (estimated)
- Study startDec 2014
- Primary completionDec 2016 (estimated)
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Traumatic Brain InjuryStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe 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
- Interventional
- Phase
- Phase N/A
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02832908
- Sponsor's protocol ID
- 9413
- Acronym
- PULSATILITY
- Status last verified
- Jul 2016
- First submitted
- 12 Jul 2016
- Last updated
- 14 Jul 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Dagod G, Roustan JP, Bringuier-Branchereau S, Ridolfo J, Martinez O, Capdevila X, Charbit J. Effect of a temporary lying position on cerebral hemodynamic and cerebral oxygenation parameters in patients with severe brain trauma. Acta Neurochir (Wien). 2021 Sep;163(9):2595-2602. doi: 10.1007/s00701-021-04851-x. Epub 2021 Jul 8.
PubMed 34236525
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Physiopathological Phenomena and the Haemodynamic and Cerebral Metabolic Effects From Semi-seated Position to Lying Position in Patients With Brain Trauma
- ClinicalTrials.gov ID
- NCT02832908
- Acronym / sponsor ID
- PULSATILITY / 9413
- Conditions
- Traumatic Brain Injury
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- Dec 2014
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 14 Jul 2016 (estimated)
- 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.
Brain trauma is an important burden in traumatologic intensive care. In these patients the treatment is guided by a cluster of multimodal monitoring parameters. Despite this it is difficult to assess the actual physiopathologic status of the brain. Changing the position of these patients (semi-seated to lying position) causes changes in the hémodynamics brain conditions, so in monitoring parameters . The analysis of these changes can givr us valuable clinically informations.
Detailed description
Severe brain trauma (CGS < 8 ) are included. PIC, PA, PVC, EKG, airway pressure, SjO2 and NIRSS are continuously monitored.
The patients are in semi seated (30°) position. Once a day they are in supine (0°) for 30 minutes. We record every parameters before and at the end of this supine period.
After time domain and frequency domain signal processing, this parameters are compared to deduct clinical relevant conclusions.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients + parents | Other | Other: Change from semi-seated position to supinePatients with severe head trauma |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- patients with a severe head trauma estimated by the Glasgow Coma Scale and by the Glasgow Outcome Scale
- age > 18
Key exclusion criteria (1 listed)
- Other neurological pathology
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 |
|---|---|---|
| Change from semi-seated position to supinefrom semi-seated position (30°) to lying position | Other | Patients + parents |
Primary outcome
ASSESSMENT OF THE CEREBRAL OXYGENATION
Time frame: UP TO 6 MONTHS
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2016.
- Derived from this study: PubMed 34236525Dagod G, Roustan JP, Bringuier-Branchereau S, Ridolfo J, Martinez O, Capdevila X, Charbit J. Effect of a temporary lying position on cerebral hemodynamic and cerebral oxygenation parameters in patients with severe brain trauma. Acta Neurochir (Wien). 2021 Sep;163(9):2595-2602. doi: 10.1007/s00701-021-04851-x. Epub 2021 Jul 8.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Change from semi-seated position to supine in people with Traumatic Brain Injury, run by University Hospital, Montpellier 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 2 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 14 Jul 2016. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jean Paul ROUSTAN, MD (0467338256, jp-roustan@chu-montpellier.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ASSESSMENT OF THE CEREBRAL OXYGENATION (time frame: UP TO 6 MONTHS). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02832908, which also lists 1 linked publication.
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 14 Jul 2016.