NCT02830269

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2016

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 10, 2016

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 12, 2016

Completed
1 month until next milestone

Study Start

First participant enrolled

August 18, 2016

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 16, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 16, 2017

Completed
Last Updated

December 5, 2018

Status Verified

April 1, 2017

Enrollment Period

9 months

First QC Date

June 10, 2016

Last Update Submit

December 4, 2018

Conditions

Keywords

Neuro-ICUThird ventricleComputer TomographyTranscranial Doppler ultrasonography

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Residents' learning curve

    24 months

Interventions

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

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

All patients admitted to the neurointensive care

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UHMontpellier

Montpellier, 34295, France

Location

Related Publications (1)

  • Widehem R, Bory P, Greco F, Pavillard F, Chalard K, Mas A, Djanikian F, Carr J, Molinari N, Jaber S, Perrigault PF, Chanques G. Transcranial sonographic assessment of the third ventricle in neuro-ICU patients to detect hydrocephalus: a diagnostic reliability pilot study. Ann Intensive Care. 2021 May 4;11(1):69. doi: 10.1186/s13613-021-00857-x.

MeSH Terms

Conditions

Brain Injuries

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemWounds and Injuries

Study Officials

  • GERALD CHANQUES, MD, Ph D

    University Hospital, Montpellier

    STUDY DIRECTOR
  • Pierre-François PERRIGAULT, MD

    University Hospital, Montpellier

    STUDY CHAIR
  • Paul BORY, MD

    University Hospital, Montpellier

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 10, 2016

First Posted

July 12, 2016

Study Start

August 18, 2016

Primary Completion

May 16, 2017

Study Completion

May 16, 2017

Last Updated

December 5, 2018

Record last verified: 2017-04

Locations