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Junior Emergency Physician Learning Curve to Perform Transcranial Doppler on Brain-damage Patients (Transcranius)

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03827421
Recruitment Status : Recruiting
First Posted : February 1, 2019
Last Update Posted : May 7, 2019
Information provided by (Responsible Party):
University Hospital, Grenoble

Brief Summary:
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.

Condition or disease
Brain Damage

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.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 75 participants
Observational Model: Other
Time Perspective: Prospective
Target Follow-Up Duration: 3 Months
Official Title: Transcranius : Junior Emergency Physician Learning Curve to Perform Transcranial Doppler on Brain-damage Patients
Actual Study Start Date : December 18, 2018
Estimated Primary Completion Date : October 2019
Estimated Study Completion Date : December 2019

Primary Outcome Measures :
  1. 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

Secondary Outcome Measures :
  1. 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

  2. Analysis of the spectral envelope quality [ Time Frame: 3 months ]
    analysis of the plot of spectral envelope: good or bad

  3. 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

  4. Analysis of the failure to perform the transcranial doppler [ Time Frame: 10 minutes ]
    number of failures to perform the transcranial doppler after 10 minutes

  5. 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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Brain-damaged patients hospitalized in neurosurgical resuscitation or intensive care unit.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03827421

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Contact: Batistin MARTINON, MD 0033476766784

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University Hospital Grenoble Recruiting
Grenoble, Auvergne Rhonalpes, France, 38043
Contact: Batistin MARTINON, MD    0033476766784   
Sub-Investigator: Perrine BOUCHEX, MD         
Sub-Investigator: Emilie BRANDINI, MD         
Sub-Investigator: Solene FREUD, MD         
Principal Investigator: Batistin MARTINON, MD         
Sponsors and Collaborators
University Hospital, Grenoble
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Principal Investigator: Batistin MARTINON, MD University Hospital, Grenoble
Additional Information:

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Responsible Party: University Hospital, Grenoble Identifier: NCT03827421    
Other Study ID Numbers: 38RC18.211
2018-A02346-49 ( Other Identifier: IDRCB )
First Posted: February 1, 2019    Key Record Dates
Last Update Posted: May 7, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Grenoble:
transcranial doppler
learning curve
traumatic brain injury
Additional relevant MeSH terms:
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Brain Injuries
Disease Attributes
Pathologic Processes
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries