ElectroencephalogramNCT03545776
Critical Care EEG Course
An observational study of Electroencephalogram and Intensive Care Units, run by Ictal Group at 6 sites in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Electroencephalogram, Intensive Care Units, Teaching Intervention
- What is being tested?
- Critical Care EEG Course
- How many people
- 100 participants
- Where
- 6 sitesFrance
- Study dates
- 22 May 2018to 1 Jul 2019
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Critical care medical and nursing staff
Who may be able to join
- Volunteers among medical and nursing ICU staff of the participating ICUs
Who cannot join
- Experienced or trained ICU staff members to EEG interpretation (pre-test score > 5/10)
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
France6 sites
Medico-Surgical Intensive Care Unit - Ambroise Pare Hospital
Boulogne-Billancourt, 92100
Department of Anesthesia and Critical Care, Beaujon Hospital
Clichy
Intensive Care Unit - Versailles Hospital
Le Chesnay, 78150
Medical Intensive Care Unit - Cochin Teaching Hospital
Paris, 75000
Medico-Surgical Intensive Care Unit - Saint Joseph Hospital
Paris, 75014
Intensive Care Unit - Foch Hospital
Suresnes, 92150
About this study
Official title: 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.
- Being tested
- Critical Care EEG Course
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Critical Care EEG CourseOther
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Critical Care EEG Course |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: at Day 90
Secondary outcomes (1)
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)
Measured: from Day 1 to Day 90 after face-to-face training
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2018
- Study start22 May 2018
- Primary completion31 May 2019
- Study completion1 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ElectroencephalogramStudies of the same condition, open and under way.
- 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
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ictal Group
- Sponsor type
- University, hospital or other
- Collaborators
- Versailles Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03545776
- Sponsor's protocol ID
- Critical Care EEG Course
- Status last verified
- Jun 2020
- First submitted
- 7 May 2018
- Last updated
- 23 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 32495314
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Teaching the Basics of Electroencephalography to Critical Care Teams
- ClinicalTrials.gov ID
- NCT03545776
- Acronym / sponsor ID
- Critical Care EEG Course
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Ictal GroupUniversity, hospital or other
- Collaborators
- Versailles Hospital
- Study start
- 22 May 2018 (actual)
- Primary completion
- 31 May 2019 (actual)
- Study completion
- 1 Jul 2019 (actual)
- First posted
- 4 Jun 2018 (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.
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 design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Educational program | – | Other: Critical Care EEG CourseMedical 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Critical care medical and nursing staff
Key inclusion criteria (1 listed)
- Volunteers among medical and nursing ICU staff of the participating ICUs
Key exclusion criteria (1 listed)
- Experienced or trained ICU staff members to EEG interpretation (pre-test score > 5/10)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Critical Care EEG CourseMedical 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 | Other | Educational program |
Primary outcome
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.
1 secondary outcome
Before/After Comparison
Time frame: from Day 1 to Day 90 after face-to-face training
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2020.
- Derived from this study: PubMed 32495314Legriel 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.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Electroencephalogram and Intensive Care Units, run by Ictal Group at 6 sites 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 1 inclusion and 1 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: finished, as of the sponsor's last update on 23 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Overall EEG interpretation (time frame: at Day 90). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03545776, which also lists 1 linked publication.
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 23 Jun 2020.