- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02549313
Effect of the Position of the Patient's Head
November 2, 2015 updated by: Centre Hospitalier Universitaire de Saint Etienne
Study of the Effect of the Position of the Patient's Head With Brain Lesions on Cerebral Blood Flow
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
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 randomization).
The patient will remain 10 minutes in each of these positions and will also have a little extra blood sample of 1 ml (ie 9 samples).
These measures will be carried out again the next day and then after five days to see if the results vary depending on the evolution of his condition.
Study Type
Observational
Enrollment (Actual)
16
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
-
-
-
Saint-etienne, France, 42000
- CHU de Saint-Etienne
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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
Sampling Method
Non-Probability Sample
Study Population
Patient with brain lesion
Description
Inclusion Criteria:
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
Exclusion Criteria:
- Hemodynamic and / or neurological instability. In the most unstable patients, care and mobilizations are reduced to a minimum.
- Craniectomy
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
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
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 °.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Cerebral oxygenation
Time Frame: day 1
|
Value of cerebral oxygenation (Hg mm) after 5 minutes in each position
|
day 1
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: LAURENT GERGELE, MD, CHU de Saint-Etienne
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
January 1, 2012
Primary Completion (Actual)
October 1, 2015
Study Completion (Actual)
October 1, 2015
Study Registration Dates
First Submitted
September 11, 2015
First Submitted That Met QC Criteria
September 11, 2015
First Posted (Estimate)
September 15, 2015
Study Record Updates
Last Update Posted (Estimate)
November 3, 2015
Last Update Submitted That Met QC Criteria
November 2, 2015
Last Verified
November 1, 2015
More Information
Terms related to this study
Other Study ID Numbers
- 1108183
- 2011-A01565-36 (Other Identifier: ANSM)
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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