Effect of the Position of the Patient's Head

Brain Lesion Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02549313
• Other study ID #: 1108183
• Secondary ID: 2011-A01565-36
• Status: Completed
• Phase: N/A
• First received: September 11, 2015
• Last updated: November 2, 2015
• Start date: January 2012
• Est. completion date: October 2015

Study information

• Verified date: November 2015
• Source: Centre Hospitalier Universitaire de Saint Etienne
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Commission nationale de l'informatique et des libertés
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: October 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Brain Lesion

Intervention

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.

Locations

Country	Name	City	State
France	CHU de SAINT-ETIENNE	Saint-etienne

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Saint Etienne

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cerebral oxygenation	Value of cerebral oxygenation (Hg mm) after 5 minutes in each position	day 1	Yes