NCT03827421

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.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
33

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Dec 2018

Geographic Reach
1 country

1 active site

Status
terminated

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 14, 2018

Completed
4 days until next milestone

Study Start

First participant enrolled

December 18, 2018

Completed
2 months until next milestone

First Posted

Study publicly available on registry

February 1, 2019

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2019

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2019

Completed
Last Updated

April 2, 2021

Status Verified

March 1, 2021

Enrollment Period

6 months

First QC Date

December 14, 2018

Last Update Submit

March 30, 2021

Conditions

Keywords

transcranial dopplerlearning curveemergencytraumatic brain injury

Outcome Measures

Primary Outcomes (1)

  • The mean number of transcranial doppler required to reach a kappa over 0,8 between the conclusions of the resident and expert.

    Learning curve

    3 months

Secondary Outcomes (5)

  • Duration in seconds for the junior to achieve the transcranial doppler

    3 months

  • Analysis of the spectral envelope quality

    3 months

  • Analysis of the evolution of the estimated difficulty of transcranial doppler realization

    3 months

  • Analysis of the failure to perform the transcranial doppler

    10 minutes

  • Analysis of the diastolic velocities and pulsatility index concordance between junior and expert

    3 months

Eligibility Criteria

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

Brain-damaged patients hospitalized in neurosurgical resuscitation or intensive care unit.

You may qualify if:

  • Adult patients : ≥ 18 year and older
  • Hospitalized in the neurosurgical resuscitation or intensive care unit
  • Brain - damaged patients

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Grenoble

Grenoble, Auvergne Rhonalpes, 38043, France

Location

MeSH Terms

Conditions

Brain InjuriesEmergenciesBrain Injuries, Traumatic

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemWounds and InjuriesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Batistin MARTINON, MD

    University Hospital, Grenoble

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Target Duration
3 Months
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 14, 2018

First Posted

February 1, 2019

Study Start

December 18, 2018

Primary Completion

June 30, 2019

Study Completion

December 31, 2019

Last Updated

April 2, 2021

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will not share

Locations