- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03545776
Critical Care EEG Course
Teaching the Basics of Electroencephalography to Critical Care Teams
Knowledge of the basic fundamental skills of electroencephalography would enable medical and nursing staffs to provide efficient and effective bedside EEG monitoring in critically ill patients.
The aim of this study is to evaluate the ability of a 10-points EEG teaching program to allow bedside caregivers (medical and nursing intensive care unit staff) interpreting EEG in the critical care setting.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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-
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Boulogne-Billancourt, France, 92100
- Medico-Surgical Intensive Care Unit - Ambroise Pare Hospital
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Clichy, France
- Department of Anesthesia and Critical Care, Beaujon Hospital
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Le Chesnay, France, 78150
- Intensive Care Unit - Versailles Hospital
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Paris, France, 75000
- Medical Intensive Care Unit - Cochin Teaching Hospital
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Paris, France, 75014
- Medico-Surgical Intensive Care Unit - Saint Joseph Hospital
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Suresnes, France, 92150
- Intensive Care Unit - Foch Hospital
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Volunteers among medical and nursing ICU staff of the participating ICUs
Exclusion Criteria:
- Experienced or trained ICU staff members to EEG interpretation (pre-test score > 5/10)
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Educational program
Medical and nursing staff will be given a 10-points EEG face-to-face initial training course that will be preceded by a pre-test evaluation and followed by delayed post-test evaluations. Training will be followed by an online teaching consisting on additional questions and answers quizzes based on the 10 educational goals already described elsewhere. In order to avoid any risk of intrasite contamination, all the learners benefiting from the training in the same department will be trained in a uniform time, with respect to the training schedule regarding post-test evaluations (day-1, day-15 and day-30). A final evaluation will be performed at day-90 after beginning of the training course. |
Medical and nursing staff will be given a 10-points EEG face-to-face initial training course followed by an online teaching and educational quizzes at day-1, day-15 and day-30 after initial training. A final evaluation will be performed at day-90 after beginning of the training course. 10-points EEG educational objectives : physiological rhythms, reactivity, symmetry, effects of sedation, burst suppression, paroxysmal activities, periodic / pseudoperiodic activities, rhythmic activities, artifacts, null EEG |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Overall EEG interpretation
Time Frame: at Day 90
|
Percentage of learners with a correct answer rate.Training will be considered as efficient if more than 75% of learners are associated with a correct answer rate above 80% to EEG interpretation test at day 90 after initial training.
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at Day 90
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Before/After Comparison
Time Frame: from Day 1 to Day 90 after face-to-face training
|
Comparison of correct answer rate between pre-test and post-tests evaluations at day 1, day 15, day 30 and day 90 after face-to-face training Analyzes will be carried out according to each of the 10-points educational goals, according to the medical or nursing staff category, according to the student's degree and according to the center and to usual way of using EEG (continuous, sequential, external provider)
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from Day 1 to Day 90 after face-to-face training
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Collaborators and Investigators
Sponsor
Collaborators
Publications and helpful links
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- Critical Care EEG Course
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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