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Individual Versus Grouped Debriefing Approaches in Anaesthesia Crisis Simulation-Based Training. What Impact On The Technical Score ? (DEBRIEF-SIM)

Primary Purpose

Cardiac Arrest, Pregnancy

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Grouped Debriefing
Individual Debriefing
Sponsored by
Centre Hospitalier Universitaire de Besancon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Cardiac Arrest focused on measuring Simulation, Debriefing, Anaesthesia Crisis Management, Cardiac Arrest, Pregnancy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Faculté de Franche-Comte des études de medecine et pharmaceutiques

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Individual Debriefing

Grouped Debriefing

Arm 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 of the management of the anaesthesia crisis simulated in the presence of all the subject included in the Grouped Debriefing group.

Outcomes

Primary Outcome Measures

Score of technical competence

Secondary Outcome Measures

Full Information

First Posted
March 29, 2013
Last Updated
October 23, 2013
Sponsor
Centre Hospitalier Universitaire de Besancon
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1. Study Identification

Unique Protocol Identification Number
NCT01835951
Brief Title
Individual Versus Grouped Debriefing Approaches in Anaesthesia Crisis Simulation-Based Training. What Impact On The Technical Score ?
Acronym
DEBRIEF-SIM
Official Title
Individual Versus Grouped Debriefing Approaches in Anaesthesia Crisis Simulation-Based Training. What Impact On The Technical Score ?
Study Type
Interventional

2. Study Status

Record Verification Date
October 2013
Overall Recruitment Status
Completed
Study Start Date
March 2013 (undefined)
Primary Completion Date
May 2013 (Actual)
Study Completion Date
October 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Centre Hospitalier Universitaire de Besancon

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiac Arrest, Pregnancy
Keywords
Simulation, Debriefing, Anaesthesia Crisis Management, Cardiac Arrest, Pregnancy

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care Provider
Allocation
Randomized
Enrollment
48 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Individual Debriefing
Arm Type
Other
Arm 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.
Arm Title
Grouped Debriefing
Arm Type
Other
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Grouped Debriefing
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Individual Debriefing
Intervention 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.
Primary Outcome Measure Information:
Title
Score of technical competence
Time Frame
2 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sébastien Pili-Floury
Organizational Affiliation
Faculté de Franche-Comté des Etudes de Médecine et Pharmaceutiques
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faculté de Franche-Comte des études de medecine et pharmaceutiques
City
Besancon
ZIP/Postal Code
25000
Country
France

12. IPD Sharing Statement

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Individual Versus Grouped Debriefing Approaches in Anaesthesia Crisis Simulation-Based Training. What Impact On The Technical Score ?

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