NCT05397756

Brief Summary

The use of simulation is recommended in anesthesiology education. Given a large number of residents, all of them will not be active participants during high-fidelity simulation sessions but will only be observers. To increase the positive effects of the simulation when the learner is in the role of observer, some authors have proposed to strengthen the educational effect through the use of an observer tool that observers must complete by analyzing the progress of the task performed by their colleagues. This is a list describing the set of key points to be achieved. However, data concerning the educational value of these observer tools are limited. Studies on the use of these tools during crisis management training in the operating room assessed by high-fidelity simulation have shown improved learning outcomes for technical skills but no study has evaluated yet their effect on non-technical skills. The effect on these skills can hardly be assessed by measuring the resident's perception or knowledge and an objective assessment of performance is necessary. The objective of this study will be to evaluate if using an observer tool (OT) dedicated to non-technical skills improves the learning of these skills in anesthesia residents during high-fidelity simulation.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
46

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2022

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

May 25, 2022

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 31, 2022

Completed
13 days until next milestone

Study Start

First participant enrolled

June 13, 2022

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 20, 2022

Completed
12 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2023

Completed
Last Updated

May 31, 2022

Status Verified

May 1, 2022

Enrollment Period

1 month

First QC Date

May 25, 2022

Last Update Submit

May 25, 2022

Conditions

Keywords

simulationeducationobserver toolnon-technical skills

Outcome Measures

Primary Outcomes (1)

  • individual performance of non-technical skills

    The primary outcome will be the individual performance of non-technical skills assessed by the ANTS score measured by an external evaluator analyzing each video (Kirkpatrick level 2) . The Anaesthetist Non-Technical Skills (ANTS) tool previously published by Fletcher et al. translated in French. The ANTS scoring system uses four categories assessing task management, teamworking, situation awareness and decision-making (1 to 4 points by categories). The minimum score is 4 and the maximum 16.

    30 min by video after the end of the session by an external evaluator

Secondary Outcomes (4)

  • each category of the ANTS score

    10 min by video after the end of the session by an external evaluator

  • Team performance

    10 min by video after the end of the session by an external evaluator

  • level of Satisfaction

    1 min and the end of the session by all residents

  • future professional impact

    1 min and the end of the session by all residents

Study Arms (2)

group (OT+)

EXPERIMENTAL

In this group (OT +), during the whole training day, the observers will use an observer tool (based on non-technical skills) when they will be not role role-playing

Other: observer tool

group (OT-)

NO INTERVENTION

In this group (OT-), the resident will not be given the observer tool and will observe other residents without any physical support.

Interventions

The observer tool used will be the Anaesthetist Non-Technical Skills (ANTS) tool previously published by Fletcher et al. and translated in French. The ANTS scoring system uses four categories assessing task management, teamworking, situation awareness and decision-making. The observers will use an observer tool it when they will be not role role-playing

group (OT+)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • all anesthesiology residents of Paris participating in a full-day of crisis management training at the LabforSIMS-Faculty of Medicine Paris-Saclay

You may not qualify if:

  • declines active participation in the session
  • previously included in a CRM training session at LabforSIMS
  • no video-recorded

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

LabForSIMS - Faculté de Médecine Paris Saclay

Le Kremlin-Bicêtre, Île-de-France Region, 94275, France

Location

Study Officials

  • Antonia Blanié, MD PhD

    LabForSIMS - Faculté de Médecine Paris Saclay

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Antonia Blanié, MD PhD

CONTACT

Dan Benhamou, MD Pr

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: Parallel assignment, not blinded, randomized study
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 25, 2022

First Posted

May 31, 2022

Study Start

June 13, 2022

Primary Completion

July 20, 2022

Study Completion

July 1, 2023

Last Updated

May 31, 2022

Record last verified: 2022-05

Data Sharing

IPD Sharing
Will not share

Locations