Cardiac ArrestDEBRIEF-SIMNCT01835951
Individual Versus Grouped Debriefing Approaches in Anaesthesia Crisis Simulation-Based Training. What Impact On The Technical Score ?
A study testing Grouped Debriefing and Individual Debriefing in people with Cardiac Arrest and Pregnancy, run by Centre Hospitalier Universitaire de Besancon at 1 site in France.
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cardiac Arrest, Pregnancy
- What is being tested?
- Grouped Debriefing and Individual Debriefing
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteFrance
- Study dates
- Mar 2013to Oct 2013
- Phase
- Interventional
- 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
Who may be able to join
- 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
Who cannot join
- Subjects incapable of giving consent: incapacitated (subjects under guardianship), minors (< 18 years)
- Refusal to participate in the study
- Refusal to sign the confidentiality clause
Trial locations and contacts
1 site in 1 country.
France1 site
Faculté de Franche-Comte des études de medecine et pharmaceutiques
Besançon, 25000
About this study
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.
- Conditions
- Cardiac Arrest, Pregnancy
- Being tested
- Grouped Debriefing, Individual Debriefing
- Keywords
- Simulation, Debriefing, Anaesthesia Crisis Management, Cardiac Arrest, Pregnancy
- Medical subject headings
- Heart Arrest
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Grouped DebriefingOther
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 DebriefingOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Individual Debriefing | Other | 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. Receives: Other: Individual Debriefing |
| Grouped Debriefing | Other | 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. Receives: Other: Grouped Debriefing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Score of technical competence
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2013 (estimated)
- Study startMar 2013
- Primary completionMay 2013
- Study completionOct 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac ArrestStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de BesanconThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Besancon
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Floriane CICERON, Centre Hospitalier Universitaire de Besancon
- Investigators
- Sébastien Pili-Floury, Principal investigator, Faculté de Franche-Comté des Etudes de Médecine et Pharmaceutiques
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01835951
- Sponsor's protocol ID
- EI/2012/028
- Acronym
- DEBRIEF-SIM
- Status last verified
- Oct 2013
- First submitted
- 29 Mar 2013
- Last updated
- 24 Oct 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Individual Versus Grouped Debriefing Approaches in Anaesthesia Crisis Simulation-Based Training. What Impact On The Technical Score ?
- ClinicalTrials.gov ID
- NCT01835951
- Acronym / sponsor ID
- DEBRIEF-SIM / EI/2012/028
- Conditions
- Cardiac Arrest, Pregnancy
- Keywords
- Simulation, Debriefing, Anaesthesia Crisis Management, Cardiac Arrest, Pregnancy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de BesanconUniversity, hospital or other
- Study start
- Mar 2013
- Primary completion
- May 2013 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 19 Apr 2013 (estimated)
- 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.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Individual Debriefing | Other | Other: Individual DebriefingIndividual 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 | Other | Other: Grouped DebriefingGrouped 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Doctor:
- Student nurse anesthesist 1st or 2nd year of school Besançon and Dijon
Key exclusion criteria (3 listed)
- Subjects incapable of giving consent: incapacitated (subjects under guardianship), minors (< 18 years)
- Refusal to participate in the study
- Refusal to sign the confidentiality clause
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 |
|---|---|---|
| Grouped DebriefingDebriefing 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. | Other | Grouped Debriefing |
| Individual DebriefingIndividual 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 |
Primary outcome
Score of technical competence
Time frame: 2 months
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 24 Oct 2013.
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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.
Sébastien Pili-Floury principal investigator
Faculté de Franche-Comté des Etudes de Médecine et Pharmaceutiques
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Grouped Debriefing and Individual Debriefing in people with Cardiac Arrest and Pregnancy, run by Centre Hospitalier Universitaire de Besancon at 1 site 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 4 inclusion and 3 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 24 Oct 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Score of technical competence (time frame: 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Oct 2013.