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Completed

NCT Number: NCT02549313

Effect of the Position of the Patient's Head

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.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU de SAINT-ETIENNE

Saint-Etienne, 42000, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

position changes of the head

Procedure

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.

Primary outcomes

  1. Cerebral oxygenation

    Time frame: day 1

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

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Saint Etienne

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Sep 15, 2015
Registry last updated
Nov 3, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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