- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02599584
Performance and Team Pre-critical Staff Before Critical Event in High Fidelity Simulation for Anesthesiology Residents (Simstaf&perf)
February 27, 2020 updated by: Lilot Marc, Claude Bernard University
Improvement of Team Performance With a Pre-critical Staff Within the Team Prior to Admission of Critical Simulated Patient in High Fidelity Simulation Session for Anesthesiology Resident During Their Education Curriculum
Simulated environment allowed safe learning of critical events and knowledge of appropriate response and treatment.
Anesthesiology resident education curriculum in Lyon plans several high fidelity simulation session with a large panel of critical events.
Anticipation of critical events before they may occur and plannification of team resources and priority in the treatment strategy may help to improve team performance during the scenario.
The investigators' goal is to compare team performance during the scenario with or without a liberal preparation team staff of 4 min, suggested after the briefing of the scenario but before the scenario starts.
Study Overview
Detailed Description
High fidelity simulated environment allowed safe learning of critical events and knowledge of appropriate response and treatment.
Anesthesiology resident education curriculum in Lyon plans several high fidelity simulation session with a large panel of critical events.
Anticipation of critical events before they may occur, plannification of team resources, priority in the treatment strategy and effective communication within the team, may help to improve team performance during the scenario.
The investigators' goal is to compare team performance during the scenario with or without a preparation team staff of 4 min.
This staff will be suggested after the briefing of the scenario but before the scenario starts.
The investigators are going to compare groups of anesthesiology residents going through same scenarios of simulated critical events in high fidelity simulation session.
Scenarios will be recorded to be analyzed by 2 reviewers independantly.
A checklist of appropriate treatment and a non technical skill checklist will be use to cote team performance.
Stress of the participants will be assessed by visual analogic scale of participants anxiety and stress.
the two groups (preparation staff or no preparation staff) will be compare to see if improvement in team performance is associated with the intervention.
Study Type
Interventional
Enrollment (Actual)
44
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Rhône-Alpes
-
Lyon, Rhône-Alpes, France, 69007
- CLESS
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Anesthesiology resident in the education simulation curriculum
Exclusion Criteria:
- no verbal consent
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: precritical staff
4 min of precritical team staff for anticipation of risk and role attribution during the critical events if they occur.
athe staff will take place after briefing of the scenario and before the start of the scenario.
|
free pre critical scenario team staff
|
No Intervention: control
screening of normal labs results during 4 min, after briefing of the scenario and before the start of the scenario
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
performance
Time Frame: one week (review video)
|
performance scale cotation (rated from 0 to 100 by 2 independant experts) (technikal and non technikal skills scale)
|
one week (review video)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
stress
Time Frame: min 0, min 4 and min 15 (just after the scenario)
|
visual analogic scale (transfer to metrics from 0 to 100) of the stress felt by the residents at the time of the cotation
|
min 0, min 4 and min 15 (just after the scenario)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: jean jacques lehot, PHD, CLESS
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2015
Primary Completion (Actual)
June 1, 2016
Study Completion (Actual)
June 1, 2016
Study Registration Dates
First Submitted
November 4, 2015
First Submitted That Met QC Criteria
November 5, 2015
First Posted (Estimate)
November 6, 2015
Study Record Updates
Last Update Posted (Actual)
March 2, 2020
Last Update Submitted That Met QC Criteria
February 27, 2020
Last Verified
February 1, 2020
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- CLESS 2015
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
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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