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

Sponsor

University Hospital, Grenoble (Other)

Overall Status

Terminated

CT.gov ID

NCT03827421

Collaborator

(none)

Enrollment

Location

12.4

Actual Duration (Months)

2.7

Patients Per Site Per Month

Study Details

Study Description

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	Intervention/Treatment	Phase
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.

Study Design

Study Type:

Observational [Patient Registry]

Actual Enrollment :

33 participants

Observational Model:

Other

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Dec 18, 2018

Actual Primary Completion Date :

Jun 30, 2019

Actual Study Completion Date :

Dec 31, 2019

Outcome Measures

Primary Outcome Measures

The mean number of transcranial doppler required to reach a kappa over 0,8 between the conclusions of the resident and expert. [3 months]
Learning curve

Secondary Outcome Measures

Duration in seconds for the junior to achieve the transcranial doppler [3 months]
Time between the beginning of the exam (ultrasound probe caring) to the velocities and pulsatility index measurements
Analysis of the spectral envelope quality [3 months]
analysis of the plot of spectral envelope: good or bad
Analysis of the evolution of the estimated difficulty of transcranial doppler realization [3 months]
evaluation of the difficulty of transcranial doppler realization: easy or difficult
Analysis of the failure to perform the transcranial doppler [10 minutes]
number of failures to perform the transcranial doppler after 10 minutes
Analysis of the diastolic velocities and pulsatility index concordance between junior and expert [3 months]
number of examen required for junior velocities measurement to reach those of the expert

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 100 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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