Effect of the Position of the Patient's Head
Study of the Effect of the Position of the Patient's Head With Brain Lesions on Cerebral Blood Flow
2 other identifiers
observational
16
1 country
1
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Jan 2012
Typical duration for all trials
1 active site
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
CompletedFirst Submitted
Initial submission to the registry
September 11, 2015
CompletedFirst Posted
Study publicly available on registry
September 15, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2015
CompletedNovember 3, 2015
November 1, 2015
3.8 years
September 11, 2015
November 2, 2015
Conditions
Keywords
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 °.
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.
Eligibility Criteria
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
Biospecimen
blood sample
Study Officials
- PRINCIPAL INVESTIGATOR
Laurent GERGELE, MD
CHU de SAINT-ETIENNE
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