NCT03545776

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2018

Geographic Reach
1 country

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 7, 2018

Completed
15 days until next milestone

Study Start

First participant enrolled

May 22, 2018

Completed
13 days until next milestone

First Posted

Study publicly available on registry

June 4, 2018

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2019

Completed
Last Updated

June 23, 2020

Status Verified

June 1, 2020

Enrollment Period

1 year

First QC Date

May 7, 2018

Last Update Submit

June 21, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Before/After Comparison

    from Day 1 to Day 90 after face-to-face training

Study Arms (1)

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.

Other: Critical Care EEG Course

Interventions

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

Educational program

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Critical care medical and nursing staff

You may qualify if:

  • Volunteers among medical and nursing ICU staff of the participating ICUs

You may not qualify if:

  • Experienced or trained ICU staff members to EEG interpretation (pre-test score \> 5/10)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Medico-Surgical Intensive Care Unit - Ambroise Pare Hospital

Boulogne-Billancourt, 92100, France

Location

Department of Anesthesia and Critical Care, Beaujon Hospital

Clichy, France

Location

Intensive Care Unit - Versailles Hospital

Le Chesnay, 78150, France

Location

Medical Intensive Care Unit - Cochin Teaching Hospital

Paris, 75000, France

Location

Medico-Surgical Intensive Care Unit - Saint Joseph Hospital

Paris, 75014, France

Location

Intensive Care Unit - Foch Hospital

Suresnes, 92150, France

Location

Related Publications (1)

  • Legriel S, Jacq G, Lalloz A, Geri G, Mahaux P, Bruel C, Brochon S, Zuber B, Andre C, Dervin K, Holleville M, Cariou A. Teaching Important Basic EEG Patterns of Bedside Electroencephalography to Critical Care Staffs: A Prospective Multicenter Study. Neurocrit Care. 2021 Feb;34(1):144-153. doi: 10.1007/s12028-020-01010-5.

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 7, 2018

First Posted

June 4, 2018

Study Start

May 22, 2018

Primary Completion

May 31, 2019

Study Completion

July 1, 2019

Last Updated

June 23, 2020

Record last verified: 2020-06

Data Sharing

IPD Sharing
Will not share

Locations