NCT02832908

Brief 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. 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2014

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2014

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

July 12, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 14, 2016

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

July 14, 2016

Status Verified

July 1, 2016

Enrollment Period

2 years

First QC Date

July 12, 2016

Last Update Submit

July 12, 2016

Conditions

Traumatic Brain Injury

Outcome Measures

Primary Outcomes (1)

  • ASSESSMENT OF THE CEREBRAL OXYGENATION

    UP TO 6 MONTHS

Study Arms (1)

Patients + parents

OTHER

Patients with severe head trauma

Other: Change from semi-seated position to supine

Interventions

Change from semi-seated position to supineOTHER

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

Patients + parents

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Other neurological pathology

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpital Lapeyronie - Département Anesthésie Réanimation A

Montpellier, 34295, France

RECRUITING

Related Publications (1)

  • 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.

    PMID: 34236525DERIVED

MeSH Terms

Conditions

Brain Injuries, Traumatic

Condition Hierarchy (Ancestors)

Brain InjuriesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemWounds and Injuries

Central Study Contacts

Jean Paul ROUSTAN, MD

CONTACT

0467338256jp-roustan@chu-montpellier.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 12, 2016

First Posted

July 14, 2016

Study Start

December 1, 2014

Primary Completion

December 1, 2016

Study Completion

December 1, 2016

Last Updated

July 14, 2016

Record last verified: 2016-07

Locations

FR(1)