Brain DamageTranscraniusNCT03827421
Junior Emergency Physician Learning Curve to Perform Transcranial Doppler on Brain-damage Patients
An observational study of Brain Damage, run by University Hospital, Grenoble at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Brain Damage
- How many people
- 33 participants
- Where
- 1 siteFrance
- Study dates
- 18 Dec 2018to 31 Dec 2019
- How long will I take part?
- 3 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Brain-damaged patients hospitalized in neurosurgical resuscitation or intensive care unit.
Who may be able to join
- Adult patients : ≥ 18 year and older
- Hospitalized in the neurosurgical resuscitation or intensive care unit
- Brain - damaged patients
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Transcranius : Junior Emergency Physician Learning Curve to Perform Transcranial Doppler on Brain-damage Patients
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.
Read the 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.
- Conditions
- Brain Damage
- Keywords
- transcranial doppler, learning curve, emergency, traumatic brain injury
- Medical subject headings
- Brain Injuries, Emergencies, Brain Injuries, Traumatic
What is being measured
The primary outcome is the main question the study is designed to answer.
The mean number of transcranial doppler required to reach a kappa over 0,8 between the conclusions of the resident and expert.
Learning curve
Measured: 3 months
Secondary outcomes (5)
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
Measured: 3 months
Analysis of the spectral envelope quality
analysis of the plot of spectral envelope: good or bad
Measured: 3 months
Analysis of the evolution of the estimated difficulty of transcranial doppler realization
evaluation of the difficulty of transcranial doppler realization: easy or difficult
Measured: 3 months
Analysis of the failure to perform the transcranial doppler
number of failures to perform the transcranial doppler after 10 minutes
Measured: 10 minutes
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
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2019
- Study start18 Dec 2018
- Primary completion30 Jun 2019
- Study completion31 Dec 2019
Why it stopped: Organizational reasons and lack of enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain DamageStudies of the same condition, open and under way.
- More trials run by University Hospital, GrenobleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 33 participants (actual)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Batistin MARTINON, MD, Principal investigator, University Hospital, Grenoble
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03827421
- Sponsor's protocol ID
- 38RC18.211
- Other IDs
- 2018-A02346-49
- Acronym
- Transcranius
- Status last verified
- Mar 2021
- First submitted
- 14 Dec 2018
- Last updated
- 2 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcranius : Junior Emergency Physician Learning Curve to Perform Transcranial Doppler on Brain-damage Patients
- ClinicalTrials.gov ID
- NCT03827421
- Acronym / sponsor ID
- Transcranius / 38RC18.211
- Conditions
- Brain Damage
- Keywords
- transcranial doppler, learning curve, emergency, traumatic brain injury
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Organizational reasons and lack of enrollment
- Enrolment
- 33 participants (actual)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Study start
- 18 Dec 2018 (actual)
- Primary completion
- 30 Jun 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 1 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 3 Months
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Brain-damaged patients hospitalized in neurosurgical resuscitation or intensive care unit.
Key inclusion criteria (3 listed)
- Adult patients : ≥ 18 year and older
- Hospitalized in the neurosurgical resuscitation or intensive care unit
- Brain - damaged patients
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
5 secondary outcomes
Duration in seconds for the junior to achieve the transcranial doppler
Time frame: 3 months
Analysis of the spectral envelope quality
Time frame: 3 months
Analysis of the evolution of the estimated difficulty of transcranial doppler realization
Time frame: 3 months
Analysis of the failure to perform the transcranial doppler
Time frame: 10 minutes
Analysis of the diastolic velocities and pulsatility index concordance between junior and expert
Time frame: 3 months
Results and safety
The study was stopped early (reason given: Organizational reasons and lack of enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Batistin MARTINON, MD principal investigator
University Hospital, Grenoble
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Brain Damage, run by University Hospital, Grenoble at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 2 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Organizational reasons and lack of enrollment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2021.