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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02830269
Recruitment Status : Completed
First Posted : July 12, 2016
Last Update Posted : December 5, 2018
Sponsor:
Information provided by (Responsible Party):
University Hospital, Montpellier

Tracking Information
First Submitted Date June 10, 2016
First Posted Date July 12, 2016
Last Update Posted Date December 5, 2018
Actual Study Start Date August 18, 2016
Actual Primary Completion Date May 16, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 8, 2016)
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.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: July 8, 2016)
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.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Third Ventricle Echographic Study for Neuro-intensive Care Unit Patients
Official Title Third Ventricle Echographic Study for Neuro-intensive Care Unit Patients
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 Type Observational
Study Design Observational Model: Other
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population All patients admitted to the neurointensive care
Condition
  • Neuro-intensive Care Unit Patients
  • Brain Injuries
Intervention Device: Transcranial Doppler ultrasonography measurements
Third ventricle diameter measurements with standard method (CT) and Transcranial Doppler ultrasonography
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: July 8, 2016)
100
Original Estimated Enrollment Same as current
Actual Study Completion Date May 16, 2017
Actual Primary Completion Date May 16, 2017   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 100 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries France
Removed Location Countries  
 
Administrative Information
NCT Number NCT02830269
Other Study ID Numbers 9720
2016-A00749-42 ( Other Identifier: RCB number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party University Hospital, Montpellier
Study Sponsor University Hospital, Montpellier
Collaborators Not Provided
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
PRS Account University Hospital, Montpellier
Verification Date April 2017