NCT04922203

Brief Summary

Since 1988, simulation has been proposed as a teaching tool in Anesthesia. The simulation environment allows to teach learners non-technical skills which are a combination of cognitive, social, and personal resources complementary to procedural skills that contribute to an efficient and safe performance. Non-technical skills traditionally used in Anesthesia are task management, situational awareness, teamwork and decision making. They can be indirectly measured with validated scales (e.g. Anesthesia Non-Technical Skills (ANTS) system). In addition to these basic skills, specific skills such as Anesthesia Crisis Resource Management (ACRM) are required when the patient presents a critical clinical situation. Simulation, as proposed by Gaba, was initially practiced in centers specifically designed for this purpose. More recently, we have proposed the model of in situ simulation, i.e. in the usual workplace with the usual work team, as another option for the practice of simulation. There are many theories about the transfer of learning. Transfer can be defined as what remains of the completed training that the learner actually uses, i.e. the final real effect. Nevertheless, almost 30 years after the introduction of simulation in the training of anesthesiologists, data demonstrating the interest of this teaching in terms of transfer of learning of non-technical skills to clinical practice or benefits for patients are rare. The main objective of this study is to evaluate the transfer of non-technical skills taught in a training program including in situ simulation to clinical practice by anesthesiology residents.

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
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2021

Longer than P75 for not_applicable

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

Study Start

First participant enrolled

May 28, 2021

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

June 4, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 10, 2021

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2024

Completed
Last Updated

June 10, 2021

Status Verified

June 1, 2021

Enrollment Period

3.3 years

First QC Date

June 4, 2021

Last Update Submit

June 9, 2021

Conditions

Outcome Measures

Primary Outcomes (3)

  • ANTS (Anesthesia non technical skills) score

    15 items - From 1(poor) to 4 (good) for each item - Minimum 15 - Maximum 60

    Once a day for 5 consecutive days between the first and the 15th day after enrollment in the study

  • ANTS (Anesthesia non technical skills) score

    15 items - From 1(poor) to 4 (good) for each item - Minimum 15 - Maximum 60

    Once a day for 5 consecutive days between the 30th and 45th day after enrollment

  • ANTS (Anesthesia non technical skills) score

    15 items - From 1(poor) to 4 (good) for each item - Minimum 15 - Maximum 60

    Once a day for 5 consecutive days between the 3rd and the 4th month after enrollment

Secondary Outcomes (3)

  • DOPS (Direct Observation of Procedural Skills) scale

    Once within the first 15 days of enrollment

  • DOPS (Direct Observation of Procedural Skills) scale

    Once between the 30th and the 45th day after enrollment

  • DOPS (Direct Observation of Procedural Skills) scale

    Once between the 3rd and the 4th month after enrollment

Study Arms (2)

Control group

NO INTERVENTION

Anesthesiology residents do not receive any in situ simulation sessions during the observation period

Simulation group

EXPERIMENTAL

Anesthesiology residents receive in situ simulations sessions during the observation period

Other: in Situ Simulation

Interventions

2 sessions of in situ simulation with 4 crisis scenarios and debriefing focused on non technical skills

Simulation group

Eligibility Criteria

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

You may qualify if:

  • \- Internship in the ambulatory surgery unit

You may not qualify if:

  • \- Refusal to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de Liège - Sart-Tilman

Liège, 4000, Belgium

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Sponsor

Study Record Dates

First Submitted

June 4, 2021

First Posted

June 10, 2021

Study Start

May 28, 2021

Primary Completion

September 30, 2024

Study Completion

September 30, 2024

Last Updated

June 10, 2021

Record last verified: 2021-06

Locations