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

Brain Damage Clinical Trial

— Transcranius  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03827421
• Other study ID #: 38RC18.211
• Secondary ID: 2018-A02346-49
• Status: Terminated
• Start date: December 18, 2018
• Est. completion date: December 31, 2019

Study information

• Verified date: March 2021
• Source: University Hospital, Grenoble
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 33
• Est. completion date: December 31, 2019
• Est. primary completion date: June 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Brain Damage
• Brain Injuries
• Emergencies

Locations

Country	Name	City	State
France	University Hospital Grenoble	Grenoble	Auvergne Rhonalpes

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Grenoble

Country where clinical trial is conducted

France, 

Outcome

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