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

July 12, 2016 updated by: University Hospital, Montpellier
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

90

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Montpellier, France, 34295
        • Recruiting
        • Hôpital Lapeyronie - Département Anesthésie Réanimation A
        • Contact:
        • Principal Investigator:
          • Jean Paul ROUSTAN, MD, phone 0467338256

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Patients + parents
Patients with severe head trauma
Other: Change from semi-seated position to supine
from semi-seated position (30°) to lying position

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
ASSESSMENT OF THE CEREBRAL OXYGENATION
Time Frame: UP TO 6 MONTHS
UP TO 6 MONTHS

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Montpellier

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2014

Primary Completion (Anticipated)

December 1, 2016

Study Completion (Anticipated)

December 1, 2016

Study Registration Dates

First Submitted

July 12, 2016

First Submitted That Met QC Criteria

July 12, 2016

First Posted (Estimate)

July 14, 2016

Study Record Updates

Last Update Posted (Estimate)

July 14, 2016

Last Update Submitted That Met QC Criteria

July 12, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 9413

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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