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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03545776
Other study ID # Critical Care EEG Course
Secondary ID
Status Completed
Phase
First received
Last updated
Start date May 22, 2018
Est. completion date July 1, 2019

Study information

Verified date June 2020
Source Ictal Group
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 100
Est. completion date July 1, 2019
Est. primary completion date May 31, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design


Intervention

Other:
Critical Care EEG 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

Locations

Country Name City State
France Medico-Surgical Intensive Care Unit - Ambroise Pare Hospital Boulogne-Billancourt
France Department of Anesthesia and Critical Care, Beaujon Hospital Clichy
France Intensive Care Unit - Versailles Hospital Le Chesnay
France Medical Intensive Care Unit - Cochin Teaching Hospital Paris
France Medico-Surgical Intensive Care Unit - Saint Joseph Hospital Paris
France Intensive Care Unit - Foch Hospital Suresnes

Sponsors (2)

Lead Sponsor Collaborator
Ictal Group Versailles Hospital

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Overall EEG interpretation 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. at Day 90
Secondary Before/After Comparison 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) from Day 1 to Day 90 after face-to-face training
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