Performance and Team Pre-critical Staff Before Critical E... | NCT02599584

Studies
Performance and Team Pre-critical Staff Before Critical Event in High Fidelity Simulation for Anesthesiology Residents

NCT02599584

Sponsor

Claude Bernard University

Status

Completed

Last Update Posted

Mar 2, 2020Actual

Enrollment

44Actual

Phase

Not Applicable

Conditions

Healthy

Interventions

precritical staff

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2015

Primary Completion Date

Jun 2016Actual

Completion Date

Jun 2016Actual

First Submitted Date

Nov 4, 2015

First Submission Date that Met QC Criteria

Nov 5, 2015

First Posted Date

Nov 6, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 27, 2020

Last Update Posted Date

Mar 2, 2020Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Lilot Marc, MD, Claude Bernard UniversityPrincipal Investigator

Lead Sponsor

Claude Bernard UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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. 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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

44Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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.	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

Interventions

Name	Type	Description	Arm Group Labels	Other Names
precritical staff	Behavioral	free pre critical scenario team staff	precritical staff

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
performance	performance scale cotation (rated from 0 to 100 by 2 independant experts) (technikal and non technikal skills scale)	one week (review video)

Secondary Outcomes

Measure	Description	Time Frame
stress	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)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Anesthesiology resident in the education simulation curriculum

Exclusion Criteria:

no verbal consent

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
jean jacques lehot, PHD	CLESS	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
CLESS		Lyon	Auvergne-Rhône-Alpes	69007	France

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D001519	Behavior

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided