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Third Ventricle Echographic Study for Neuro-intensive Care Unit Patients (ECHO-V3)

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ClinicalTrials.gov Identifier: NCT02830269
Recruitment Status : Recruiting
First Posted : July 12, 2016
Last Update Posted : October 18, 2017
Sponsor:
Information provided by (Responsible Party):
University Hospital, Montpellier

Brief Summary:
Transcranial Doppler ultrasonography is usually used in the evaluation and management of patients with brain injury. This noninvasive method measures local blood flow velocity and direction in the proximal portions of large intracranial arteries. The operator requires a short training and experience to perform. The third ventricle diameter measurement by transcranial duplex flow sonography was performed in healthy volunteers . This studies show similar results in those obtained with the MRI or Computer Tomography (CT). Currently the third ventricle diameter measurements by transcranial Doppler ultrasonography was not validated for neuro-intensive care unit patients. The investigators propose to used recent ultrasound system to validate the third ventricle diameter measurements in comparison with the standard method (CT).

Condition or disease Intervention/treatment
Neuro-intensive Care Unit Patients Brain Injuries Device: Transcranial Doppler ultrasonography measurements

Detailed Description:
Transcranial Doppler ultrasonography is usually used in the evaluation and management of patients with brain injury. This noninvasive method measures local blood flow velocity and direction in the proximal portions of large intracranial arteries. The operator requires a short training and experience to perform. The third ventricle diameter measurement by transcranial duplex flow sonography was performed in healthy volunteers . This studies show similar results in those obtained with the MRI or Computer Tomography (CT). Currently the third ventricle diameter measurements by transcranial Doppler

Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Third Ventricle Echographic Study for Neuro-intensive Care Unit Patients
Actual Study Start Date : August 18, 2016
Estimated Primary Completion Date : February 18, 2018
Estimated Study Completion Date : February 18, 2018

Resource links provided by the National Library of Medicine



Intervention Details:
  • Device: Transcranial Doppler ultrasonography measurements
    Third ventricle diameter measurements with standard method (CT) and Transcranial Doppler ultrasonography


Primary Outcome Measures :
  1. Third ventricle diameter (average +/- standard deviation) [ Time Frame: Through study completion (30 months) ]
    Spearman's test measuring the correlation coefficient between the third ventricle diameter measured by the expert using the ultrasonography and the third ventricle diameter measured by CT scan.


Secondary Outcome Measures :
  1. Residents' learning curve [ Time Frame: 24 months ]
    The learning curve will be determined by the change in the third ventricle diameter's difference obtained by the expert and the resident, divided by the diameter obtained by the expert reported on the Y-axis and the number of measures done by the resident reported on the X-axis. Number of measures to be done will be determined when the curve reached the zero.



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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
All patients admitted to the neurointensive care
Criteria

Inclusion Criteria:

  • Adult, > or equal to 18-yr
  • Admission to neuro-intensive care unit with brain injury
  • Evaluation by Computer Tomography
  • Indication for Transcranial Doppler ultrasonography

Exclusion Criteria:

  • Opposition to participate by the patient or a next of kin

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02830269


Contacts
Contact: GERALD CHANQUES, MD, Ph D +33467337271 g-chanques@chu-montpellier.fr
Contact: Pierre-François PERRIGAULT, MD +33467337271 pf-perrigault@chu-montpellier.fr

Locations
France
UHMontpellier Recruiting
Montpellier, France, 34295
Contact: GERALD CHANQUES, MD PHD    +33467337271    g-chanques@chu-montpellier.fr   
Sponsors and Collaborators
University Hospital, Montpellier
Investigators
Study Director: GERALD CHANQUES, MD, Ph D University Hospital, Montpellier
Study Chair: Pierre-François PERRIGAULT, MD University Hospital, Montpellier
Principal Investigator: Paul BORY, MD University Hospital, Montpellier

Responsible Party: University Hospital, Montpellier
ClinicalTrials.gov Identifier: NCT02830269     History of Changes
Other Study ID Numbers: 9720
2016-A00749-42 ( Other Identifier: RCB number )
First Posted: July 12, 2016    Key Record Dates
Last Update Posted: October 18, 2017
Last Verified: April 2017

Keywords provided by University Hospital, Montpellier:
Neuro-ICU
Third ventricle
Computer Tomography
Transcranial Doppler ultrasonography

Additional relevant MeSH terms:
Brain Injuries
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries