- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03827421
Junior Emergency Physician Learning Curve to Perform Transcranial Doppler on Brain-damage Patients (Transcranius)
March 30, 2021 updated by: University Hospital, Grenoble
Transcranius : Junior Emergency Physician Learning Curve to Perform Transcranial Doppler on Brain-damage Patients
Transcranial Doppler is a noninvasive tool.
Using velocity measurements and pulsatility index it allows the evaluation of cerebral haemodynamics.
In patients presenting brain injury cerebral perfusion may be impaired.
Indirect cerebral blood flow can be monitored and risk of neurological worsening can be detected using transcranial Doppler.
Education and performance of emergency physicians must be evaluated on brain-injured patients because this tool is operator dependent.
The main objective of this study is to estimate the average number of exams required to learn transcranial Doppler within junior emergency physicians with the achievement of their learning curve.
We will perform a prospective, monocentric, observational study within the neurosurgical resuscitation department of Grenoble Alpes University Hospital.
Study Overview
Status
Terminated
Conditions
Detailed Description
The transcranial dopplers will be carry out on 75 brain-damaged patients by 13 emergency residents physicians after a theoretical and practical training.
They will be evaluated by 8 experts.
The primary endpoint will be the mean number of transcranial dopplers required to have an excellent concordance between resident and expert.
The concordance between the Doppler findings of the resident and the expert would exceed 0.8 before 30 examinations.
The learning curve assessed on the duration necessary to acquire good quality data should decrease rapidly with the repetition of the examinations.
Validating the transcranial Doppler learning curve for junior emergency physician would allow them to perform this exam safely and efficiently.
Transcranial Doppler may be easy and fast to learn but the persistence of its competency over time should be evaluated.
Study Type
Observational
Enrollment (Actual)
33
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
-
-
Auvergne Rhonalpes
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Grenoble, Auvergne Rhonalpes, France, 38043
- University Hospital Grenoble
-
-
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
Non-Probability Sample
Study Population
Brain-damaged patients hospitalized in neurosurgical resuscitation or intensive care unit.
Description
Inclusion Criteria:
- Adult patients : ≥ 18 year and older
- Hospitalized in the neurosurgical resuscitation or intensive care unit
- Brain - damaged patients
Exclusion Criteria:
- Any craniotemporal lesion impeding satisfactory TDC examination : no transtemporal doppler window, patient with craniectomy.
- Patient with meningo-encephalitis
- Patient with cerebral vasculitis
- Patient without health insurance coverage
- Patient subject to a legal protection measure
- Pregnant woman , parturient or nursing
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 |
---|---|---|
The mean number of transcranial doppler required to reach a kappa over 0,8 between the conclusions of the resident and expert.
Time Frame: 3 months
|
Learning curve
|
3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Duration in seconds for the junior to achieve the transcranial doppler
Time Frame: 3 months
|
Time between the beginning of the exam (ultrasound probe caring) to the velocities and pulsatility index measurements
|
3 months
|
Analysis of the spectral envelope quality
Time Frame: 3 months
|
analysis of the plot of spectral envelope: good or bad
|
3 months
|
Analysis of the evolution of the estimated difficulty of transcranial doppler realization
Time Frame: 3 months
|
evaluation of the difficulty of transcranial doppler realization: easy or difficult
|
3 months
|
Analysis of the failure to perform the transcranial doppler
Time Frame: 10 minutes
|
number of failures to perform the transcranial doppler after 10 minutes
|
10 minutes
|
Analysis of the diastolic velocities and pulsatility index concordance between junior and expert
Time Frame: 3 months
|
number of examen required for junior velocities measurement to reach those of the expert
|
3 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Batistin MARTINON, MD, University Hospital, Grenoble
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)
December 18, 2018
Primary Completion (Actual)
June 30, 2019
Study Completion (Actual)
December 31, 2019
Study Registration Dates
First Submitted
December 14, 2018
First Submitted That Met QC Criteria
January 31, 2019
First Posted (Actual)
February 1, 2019
Study Record Updates
Last Update Posted (Actual)
April 2, 2021
Last Update Submitted That Met QC Criteria
March 30, 2021
Last Verified
March 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 38RC18.211
- 2018-A02346-49 (Other Identifier: IDRCB)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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