- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01835951
Individual Versus Grouped Debriefing Approaches in Anaesthesia Crisis Simulation-Based Training. What Impact On The Technical Score ? (DEBRIEF-SIM)
Simulation-based training is essential in learning or maintaining skills in high risk industry such as aviation and railway and in the medical field like anaesthesia. Debriefing following simulation is fundamental in order to reduce the emotional impact of the session and to asses the technical and non-technical skills (behavior). Even if the ideal debriefing method is still to be found, individual debriefing is considered as the gold standard but time consuming. The DEBRIEF-SIM study is a prospective, single blinded, multicentric and randomized study that will compare the individual (defined by learning couple resident and nurse) approach to a grouped (several couples) debriefing. The primary end point is to define the noninferiority of this approach compared to the individual one on the educational impact.
The learners will be debriefed according to their randomization after the first session, but will all undergo individual debriefing following the second session.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Individual debriefing consists in a individual meeting between each subject of the study and the investigator to analyze the management of the anaesthesia crisis simulated.
Grouped debriefing consists in the analysis by the investigator of the management of the anaesthesia crisis simulated in the presence of all the subjects included in the Grouped Debriefing group.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Besancon, France, 25000
- Faculté de Franche-Comte des études de medecine et pharmaceutiques
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
Doctor:
- resident in anesthesia and intensive care CHU Besançon and Dijon
Student nurse anesthetist:
- Student nurse anesthesist 1st or 2nd year of school Besançon and Dijon
Exclusion Criteria:
- Subjects incapable of giving consent: incapacitated (subjects under guardianship), minors (< 18 years)
- Refusal to participate in the study
- Refusal to sign the confidentiality clause
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: Individual Debriefing
Individual debriefing consists in a individual meeting between each subject of the study and the investigator to analyze the management of the anaesthesia crisis simulated.
|
Individual debriefing consists in a individual meeting between each subject of the study and the investigator to analyze the management of the anaesthesia crisis simulated.
|
|
Other: Grouped Debriefing
Grouped debriefing consists in the analysis of the management of the anaesthesia crisis simulated in the presence of all the subject included in the Grouped Debriefing group.
|
Debriefing consists in an analysis by the investigator of the management of the anaesthesia crisis simulated in the presence of all the subjects included in the Groupe Debriefing group.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Score of technical competence
Time Frame: 2 months
|
2 months
|
Collaborators and Investigators
Investigators
- Principal Investigator: Sébastien Pili-Floury, Faculté de Franche-Comte des études de medecine et pharmaceutiques
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- EI/2012/028
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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