Third Ventricle Echographic Study for Neuro-intensive Care Unit Patients

Completed

• Conditions: Brain Injuries; Neuro-intensive Care Unit Patients

• Registration Number: NCT02830269
• Lead Sponsor: 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).

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 Timeline

• Study First Submitted: 2016-06-10
• Study First Submitted QC: 2016-07-08
• Study First Posted: 2016-07-12
• Study Start: 2016-08-18
• Status Verified: 2017-04
• Primary Completion: 2017-05-16
• Study Completion: 2017-05-16
• Last Update Submitted: 2018-12-04
• Last Update Posted: 2018-12-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Third ventricle diameter (average +/- standard deviation)	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

Name	Time	Method
Residents' learning curve	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.

Trial Locations

Locations (1)

UHMontpellier; 🇫🇷 Montpellier, France