Clinical Trials Logo

Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT03827421
Other study ID # 38RC18.211
Secondary ID 2018-A02346-49
Status Terminated
Phase
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
See also
  Status Clinical Trial Phase
Active, not recruiting NCT04546737 - Study of Morphological, Spectral and Metabolic Manifestations of Neurological Complications in Covid-19 Patients N/A
Recruiting NCT05134116 - SafeBoosC III Two-year Follow-up
Completed NCT03712839 - Cognitive-functional Evaluation of Anosognosia
Completed NCT03958487 - An Executive/Monitoring Treatment Protocol on Everyday Life Activities N/A
Recruiting NCT06083233 - Role of Brain Specific Biomarkers in Hydrocephalus N/A
Recruiting NCT05692804 - Evaluation of Neuronal Damage in Patients Undergoing Robot-assisted Laparoscopic Radical Prostatectomy With Biomarkers
Recruiting NCT06027645 - Early Intervention Based on Neonatal Crawling in Very Premature Infants at Risk For Neurodevelopmental Disorder N/A
Completed NCT04052087 - Cross-cultural Adaptation to the Spanish Population and Validation of the BESTest and Mini-BESTest
Completed NCT01076257 - Efficacy of Modified Constraint-induced Movement Therapy in Children With Brain Damage N/A
Recruiting NCT03191409 - Interaction Research on Cognitive Impairment and Emotional Disorder in End-stage Renal Disease N/A
Completed NCT03823430 - Pupillometry : Predictive Indicator in External Ventricular Drain Clamping ?
Enrolling by invitation NCT05864677 - Cerebrolysin in Prevention of Postoperative Delirium in Cardiac Surgery N/A
Completed NCT04368052 - Liver Transplant Does it Affect the Brain N/A
Completed NCT04419818 - A Neuropsychological Test Battery for the Assessment of Time Deficits
Completed NCT04373837 - Rehabilitation Treatment of Time Deficits in Brain-damaged Patients N/A
Recruiting NCT05399602 - The Role of Neurofilament Light (NfL) in Patients With Hydrocephalus N/A
Recruiting NCT03344731 - Cognitive Abilities in Brain Damaged Patients N/A
Completed NCT04846738 - Transcranial Doppler and Quantitative Pupillometry as Neurological Prognostic Factors in Brain Damaged Patients Admitted to Intensive Care Unit