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

Traumatic Brain Injury Clinical Trial

— PULSATILITY  

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02832908
• Other study ID #: 9413
• Status: Recruiting
• Phase: N/A
• First received: July 12, 2016
• Last updated: July 12, 2016
• Start date: December 2014
• Est. completion date: December 2016

Study information

• Verified date: July 2016
• Source: University Hospital, Montpellier
• Contact: Jean Paul ROUSTAN, MD
• Phone: 0467338256
• Email: jp-roustan[@]chu-montpellier.fr
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Brain Injuries
• Traumatic Brain Injury

Intervention

Other:
• Change from semi-seated position to supine
from semi-seated position (30°) to lying position

Locations

Country	Name	City	State
France	Hôpital Lapeyronie - Département Anesthésie Réanimation A	Montpellier

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Montpellier

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ASSESSMENT OF THE CEREBRAL OXYGENATION		UP TO 6 MONTHS	No