Evaluation of the Physiopathological Phenomena and the Haemodynamic and Cerebral Metabolic Effects From Semi-seated Position to Lying Position in Patients With Brain Trauma

NCT ID: NCT02832908

Last Updated: 2016-07-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-12-31

Study Completion Date

2016-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Traumatic Brain Injury

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Patients + parents

Patients with severe head trauma

Group Type OTHER

Change from semi-seated position to supine

Intervention Type OTHER

from semi-seated position (30°) to lying position

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Change from semi-seated position to supine

from semi-seated position (30°) to lying position

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* patients with a severe head trauma estimated by the Glasgow Coma Scale and by the Glasgow Outcome Scale
* age \> 18

Exclusion Criteria

* Other neurological pathology
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University Hospital, Montpellier

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Hôpital Lapeyronie - Département Anesthésie Réanimation A

Montpellier, , France

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

France

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Jean Paul ROUSTAN, MD

Role: CONTACT

0467338256

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Jean Paul ROUSTAN, MD

Role: primary

04 67 33 82 56

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 34236525 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

9413

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Prognosis of Brain Reflexes
NCT02395861 UNKNOWN NA