NCT02926599

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 planification of team resources and priority in the treatment strategy may help to improve team performance during the scenario. The investigators' goal is to compare individual and team performances with or without an optimization personal potential training.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
118

participants targeted

Target at P75+ for not_applicable healthy

Timeline
Completed

Started Sep 2016

Typical duration for not_applicable healthy

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

September 1, 2016

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

September 30, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 6, 2016

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2017

Completed
Last Updated

August 21, 2018

Status Verified

August 1, 2018

Enrollment Period

1 year

First QC Date

September 30, 2016

Last Update Submit

August 19, 2018

Conditions

Keywords

High Fidelity Simulation

Outcome Measures

Primary Outcomes (1)

  • Performance during simulation

    Performance will be assessed by the sum of 3 assessment: Ottawa non technical skill scale, team scanle and specific technical skill scale Total will be a number from 0 to 100.

    day 1

Secondary Outcomes (2)

  • visual analogic scale of anxiety

    day 1

  • Visual analogic scales of confidence

    day 1

Other Outcomes (2)

  • psychometric POMS scales

    day 1

  • psychometric STAI scales

    day 1

Study Arms (2)

Personal Optimization Training

EXPERIMENTAL

Personal Optimization Training such as positive reinforcement, personalized psycho-physiological relaxation and mental rehearsal (total 5 hours a few weeks before the simulation). Having 2 min to focus on techniques they were trained, after briefing of the scenario and before the start of the scenario.

Behavioral: Personal Optimization Training

Control

NO INTERVENTION

No particular training. Screening of normal labs results during 2 min, after briefing of the scenario and before the start of the scenario.

Interventions

Personal Optimization Training

Eligibility Criteria

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

You may qualify if:

  • Anesthesiology and Intensive care resident in the simulation education curriculum

You may not qualify if:

  • Refusal to participate (written approval required)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CLESS

Lyon, Auvergne-Rhône-Alpes, 69007, France

Location

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

September 30, 2016

First Posted

October 6, 2016

Study Start

September 1, 2016

Primary Completion

September 1, 2017

Study Completion

October 1, 2017

Last Updated

August 21, 2018

Record last verified: 2018-08

Locations