Third Ventricle Echographic Study for Neuro-intensive Care Unit Patients

Brain Injuries Clinical Trial

— ECHO-V3  

Official title:

Third Ventricle Echographic Study for Neuro-intensive Care Unit Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02830269
• Other study ID #: 9720
• Secondary ID: 2016-A00749-42
• Status: Completed
• Start date: August 18, 2016
• Est. completion date: May 16, 2017

Study information

• Verified date: April 2017
• Source: University Hospital, Montpellier
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: May 16, 2017
• Est. primary completion date: May 16, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Brain Injuries
• Neuro-intensive Care Unit Patients

Intervention

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

Locations

Country	Name	City	State
France	UHMontpellier	Montpellier

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Montpellier

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Third ventricle diameter (average +/- standard deviation)	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	Residents' learning curve	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