NCT02599584

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
44

participants targeted

Target at P50-P75 for not_applicable healthy

Timeline
Completed

Started Nov 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2015

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

November 4, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 6, 2015

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
Last Updated

March 2, 2020

Status Verified

February 1, 2020

Enrollment Period

7 months

First QC Date

November 4, 2015

Last Update Submit

February 27, 2020

Conditions

Healthy

Keywords

behaviour

Outcome Measures

Primary Outcomes (1)

  • 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 (1)

  • stress

    min 0, min 4 and min 15 (just after the scenario)

Study Arms (2)

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

precritical staffBEHAVIORAL

free pre critical scenario team staff

precritical staff

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Anesthesiology resident in the education simulation curriculum

You may not qualify if:

  • no verbal consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CLESS

Lyon, Auvergne-Rhône-Alpes, 69007, France

Location

MeSH Terms

Conditions

Behavior

Study Officials

  • jean jacques lehot, PHD

    CLESS

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

November 4, 2015

First Posted

November 6, 2015

Study Start

November 1, 2015

Primary Completion

June 1, 2016

Study Completion

June 1, 2016

Last Updated

March 2, 2020

Record last verified: 2020-02

Locations

FR(1)