Junior Emergency Physician Learning Curve to Perform Tran... | NCT03827421

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

NCT03827421

Sponsor

University Hospital, Grenoble

Status

Terminated

Last Update Posted

Apr 2, 2021Actual

Enrollment

33Actual

Phase

Not provided

Conditions

Brain Damage

Interventions

Not provided

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
2018-A02346-49	Other Identifier	IDRCB

Status Module

Record Verification Date

Mar 2021

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Organizational reasons and lack of enrollment

Expanded Access Info

Start Date

Dec 18, 2018Actual

Primary Completion Date

Jun 30, 2019Actual

Completion Date

Dec 31, 2019Actual

First Submitted Date

Dec 14, 2018

First Submission Date that Met QC Criteria

Jan 31, 2019

First Posted Date

Feb 1, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 30, 2021

Last Update Posted Date

Apr 2, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

3 Months

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

33Actual

Outcomes Module

Primary Outcomes

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.	Learning curve	3 months

Secondary Outcomes

Measure	Description	Time Frame
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
Analysis of the spectral envelope quality

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

100 Years

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Batistin MARTINON, MD	University Hospital, Grenoble	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Hospital Grenoble		Grenoble	Auvergne Rhonalpes	38043	France

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D001930	Brain Injuries
D004630	Emergencies
D000070642	Brain Injuries, Traumatic

Ancestor Terms

ID	Term
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases
D006259	Craniocerebral Trauma

Browse Leaves

Not provided

Browse Branches

Not provided