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
      • 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.

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

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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