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CompletedNCT01835951DEBRIEF-SIMUpdated Oct 24, 2013

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

An interventional study of Grouped Debriefing and Individual Debriefing in Cardiac Arrest and Pregnancy, sponsored by Centre Hospitalier Universitaire de Besancon. Completed at 1 site in France. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2013-10-24.

Sponsored by Centre Hospitalier Universitaire de Besancon · Not applicable, Interventional, and Health services research

Phase
Not applicable
Study type
Interventional
Enrollment
48
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Cardiac Arrest
  • Pregnancy

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Keywords

  • Simulation
  • Debriefing
  • Anaesthesia Crisis Management
  • Cardiac Arrest
  • Pregnancy
03

In context

Heart Arrest

984 studies on the registry are indexed under Heart Arrest; 227 are open to participants now.

This study's planned enrollment of 48 is below the median of 100 across 563 interventional studies indexed under Heart Arrest.

Browse Heart Arrest studies →

Lead sponsor

Centre Hospitalier Universitaire de Besancon is the lead sponsor of 449 studies on the registry; 98 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Care provider)
Enrollment
48 participants (estimated)

Study arms

  • 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.

    Other: Individual Debriefing

  • 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.

    Other: Grouped Debriefing

Interventions

  • OtherGrouped 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.

  • OtherIndividual 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.

06

What researchers measure

Primary outcomes

  1. Score of technical competence

    Time frame: 2 months

07

Study locations

1 site
  • Faculté de Franche-Comte des études de medecine et pharmaceutiques
    Besançon, 25000, France
08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Mar 2013, a primary completion of May 2013 and a completion of Oct 2013. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 29, 2013
First posted
Apr 19, 2013
Start
Mar 2013
Primary completionActual
May 2013
CompletionActual
Oct 2013
Last update
Oct 24, 2013
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Oct 24, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01835951
Responsible party
Floriane CICERON (Anesthesia-reanimation internal, Centre Hospitalier Universitaire de Besancon) — Principal investigator
First posted
Apr 19, 2013
Start date
Mar 2013
Primary completion
May 2013
Completion
Oct 2013
Last update
Oct 24, 2013

Study contacts

Sébastien Pili-Floury
principal investigator · Faculté de Franche-Comté des Etudes de Médecine et Pharmaceutiques

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Oct 2013. You cannot join it, but the record below documents what was studied.

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