HealthySimstaf&perfNCT02599584
Performance and Team Pre-critical Staff Before Critical Event in High Fidelity Simulation for Anesthesiology Residents
A study testing precritical staff in people with Healthy, run by Claude Bernard University at 1 site in France.
Trial summary
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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- precritical staff
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteFrance
- Study dates
- Nov 2015to Jun 2016
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Anesthesiology resident in the education simulation curriculum
Who cannot join
- no verbal consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Healthy
- Being tested
- precritical staff
- Keywords
- behaviour
- Medical subject headings
- Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
precritical staffBehavioural
free pre critical scenario team staff
| Study group | Role | What they receive |
|---|---|---|
| precritical staff | Experimental | 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. Receives: Behavioral: precritical staff |
| control | No intervention | screening of normal labs results during 4 min, after briefing of the scenario and before the start of the scenario |
What is being measured
The primary outcome is the main question the study is designed to answer.
performance
performance scale cotation (rated from 0 to 100 by 2 independant experts) (technikal and non technikal skills scale)
Measured: one week (review video)
Secondary outcomes (1)
stress
visual analogic scale (transfer to metrics from 0 to 100) of the stress felt by the residents at the time of the cotation
Measured: min 0, min 4 and min 15 (just after the scenario)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2015 (estimated)
- Study startNov 2015
- Primary completionJun 2016
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Claude Bernard University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lilot Marc, Claude Bernard University
- Investigators
- jean jacques lehot, PHD, Study chair, CLESS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02599584
- Sponsor's protocol ID
- CLESS 2015
- Acronym
- Simstaf&perf
- Status last verified
- Feb 2020
- First submitted
- 4 Nov 2015
- Last updated
- 2 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT02599584
- Acronym / sponsor ID
- Simstaf&perf / CLESS 2015
- Conditions
- Healthy
- Keywords
- behaviour
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Claude Bernard UniversityUniversity, hospital or other
- Study start
- Nov 2015
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 6 Nov 2015 (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.
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.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| precritical staff | Experimental | Behavioral: precritical staff4 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. |
| control | No intervention | –screening of normal labs results during 4 min, after briefing of the scenario and before the start of the scenario |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Anesthesiology resident in the education simulation curriculum
Key exclusion criteria (1 listed)
- no verbal consent
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 |
|---|---|---|
| precritical stafffree pre critical scenario team staff | Behavioural | precritical staff |
Primary outcome
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)
1 secondary outcome
stress
Time frame: min 0, min 4 and min 15 (just after the scenario)
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 2 Mar 2020.
- Individual participant dataSharing planned: Undecided
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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.
jean jacques lehot, PHD study chair
CLESS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing precritical staff in people with Healthy, run by Claude Bernard University 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 1 inclusion and 1 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 2 Mar 2020. 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?
performance (time frame: one week (review video)). 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 2 Mar 2020.