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

December 4, 2018 updated by: University Hospital, Montpellier
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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

100

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

  • France
      • Montpellier, France, 34295
        • Uhmontpellier

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 to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

All patients admitted to the neurointensive care

Description

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

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Through study completion (30 months)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Actual)

August 18, 2016

Primary Completion (Actual)

May 16, 2017

Study Completion (Actual)

May 16, 2017

Study Registration Dates

First Submitted

June 10, 2016

First Submitted That Met QC Criteria

July 8, 2016

First Posted (Estimate)

July 12, 2016

Study Record Updates

Last Update Posted (Actual)

December 5, 2018

Last Update Submitted That Met QC Criteria

December 4, 2018

Last Verified

April 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 9720
  • 2016-A00749-42 (Other Identifier: RCB number)

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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