Effect of the Position of the Patient's Head

Sponsor

Centre Hospitalier Universitaire de Saint Etienne (Other)

Overall Status

Completed

CT.gov ID

NCT02549313

Collaborator

(none)

Enrollment

Location

Duration (Months)

0.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Brain Lesion	Procedure: position changes of the head

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 Design

Study Type:

Observational

Actual Enrollment :

16 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Study of the Effect of the Position of the Patient's Head With Brain Lesions on Cerebral Blood Flow

Study Start Date :

Jan 1, 2012

Actual Primary Completion Date :

Oct 1, 2015

Actual Study Completion Date :

Oct 1, 2015

Arms and Interventions

Arm	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 °.	Procedure: 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 ° (the order of actions will be determined by drawing lots). The patient will remain 10 minutes in each of these positions.

Arm

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 °.

Procedure: 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 ° (the order of actions will be determined by drawing lots). The patient will remain 10 minutes in each of these positions.

Outcome Measures

Primary Outcome Measures

Cerebral oxygenation [day 1]
Value of cerebral oxygenation (Hg mm) after 5 minutes in each position

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CHU de SAINT-ETIENNE	Saint-etienne		France	42000

Sponsors and Collaborators

Centre Hospitalier Universitaire de Saint Etienne

Investigators

Principal Investigator: Laurent GERGELE, MD, CHU de SAINT-ETIENNE

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Centre Hospitalier Universitaire de Saint Etienne

ClinicalTrials.gov Identifier:

NCT02549313

Other Study ID Numbers:

1108183
2011-A01565-36

First Posted:

Sep 15, 2015

Last Update Posted:

Nov 3, 2015

Last Verified:

Nov 1, 2015

Keywords provided by Centre Hospitalier Universitaire de Saint Etienne

brain lesion

intracranial pressure

cerebral perfusion pressure

Study Results

No Results Posted as of Nov 3, 2015