NCT02549313

Brief Summary

The position of the head of the patient influences the cerebral venous return and cerebral perfusion pressure (CPP). In our daily practice, it is almost routine to prescribe a Trendelenburg position 30 ° in all brain-damaged patients. However, this is based only on precarious bibliographic databases. It has been shown to decrease the Intracranial Pressure (ICP) in Trendelenburg position relative to the horizontal, with varying effects on PPC. Effects on sylvian objectified by Doppler velocities and cerebral oxygenation seem unaffected by changes of position of the head of the patient. But the whole of the literature on this subject has significant bias.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
16

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2012

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2012

Completed
3.7 years until next milestone

First Submitted

Initial submission to the registry

September 11, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 15, 2015

Completed
16 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2015

Completed
Last Updated

November 3, 2015

Status Verified

November 1, 2015

Enrollment Period

3.8 years

First QC Date

September 11, 2015

Last Update Submit

November 2, 2015

Conditions

Keywords

brain lesionintracranial pressurecerebral perfusion pressure

Outcome Measures

Primary Outcomes (1)

  • Cerebral oxygenation

    Value of cerebral oxygenation (Hg mm) after 5 minutes in each position

    day 1

Study Arms (1)

position changes of head with brain lesion

patient with position changes of the head: registration of blood flow changes induced when the patient's head will be tilted at 0 ° (that is to say flat), 15 ° and 30 °.

Procedure: position changes of the head

Interventions

Registration of blood flow changes induced when the patient's head will be tilted at 0 ° (that is to say flat), 15 ° and 30 ° (the order of actions will be determined by drawing lots). The patient will remain 10 minutes in each of these positions.

position changes of head with brain lesion

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patient with brain lesion

You may qualify if:

  • Patients aged over 18 years with:
  • A severe head injury
  • or subarachnoid hemorrhage before the 5th day of evolution
  • or spontaneous intracranial hematoma
  • or ischemic stroke
  • Neurosurgical Patients after surgery
  • Presenting intracranial hypertension

You may not qualify if:

  • Hemodynamic and / or neurological instability. In the most unstable patients, care and mobilizations are reduced to a minimum.
  • Craniectomy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de SAINT-ETIENNE

Saint-Etienne, 42000, France

Location

Biospecimen

Retention: SAMPLES WITH DNA

blood sample

Study Officials

  • Laurent GERGELE, MD

    CHU de SAINT-ETIENNE

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 11, 2015

First Posted

September 15, 2015

Study Start

January 1, 2012

Primary Completion

October 1, 2015

Study Completion

October 1, 2015

Last Updated

November 3, 2015

Record last verified: 2015-11

Locations