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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01835951
Other study ID # EI/2012/028
Secondary ID
Status Completed
Phase N/A
First received March 29, 2013
Last updated October 23, 2013
Start date March 2013
Est. completion date October 2013

Study information

Verified date October 2013
Source Centre Hospitalier Universitaire de Besancon
Contact n/a
Is FDA regulated No
Health authority France: Ministère de l'Enseignement supérieur et de la Recherche
Study type Interventional

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 48
Est. completion date October 2013
Est. primary completion date May 2013
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years and older
Eligibility 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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Caregiver), Primary Purpose: Health Services Research


Related Conditions & MeSH terms


Intervention

Other:
Grouped Debriefing
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.
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.

Locations

Country Name City State
France Faculté de Franche-Comte des études de medecine et pharmaceutiques Besancon

Sponsors (1)

Lead Sponsor Collaborator
Centre Hospitalier Universitaire de Besancon

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Score of technical competence 2 months No
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