NCT02722226

Brief Summary

Objective Sedation is a depression of consciousness varies between anxiolysis and general anesthesia. It is used to facilitate diagnostic tests and minor surgeries. Respiratory complication is the main side effect of the sedation. His Early diagnosis and adequate management prevent serious complications such as hypoxic brain damage or death. A development of a learning program of sedation is required. Simulation as a teaching tool has improved the clinical expertise of learners. The objective of the study is to evaluate the impact of a simulation based medical education program on the performance of non-resident anesthesiologists for the management of complications related to sedation. Methods This trial is randomized, controlled and single blinded. Non-resident anesthesiologists, without prior training on sedation, are included and randomized to receive or not a simulation based sedation learning. This program includes a pharmacology sedatives learning, teaching technical skills for airway management on low fidelity mannequin and high-fidelity simulation scenarios of these complications. Two evaluators, single-blinded, visualise the recorded performance of residents in simulation session. The evaluation is based on a performance checklist developed by Delphi technique. It compares the performance of the residents within the same group before and after the simulation based medical education program and to compare groups of residents. Data analysis The sample size is based on similar simulation studies. The results are compared with the variance analysis for repeated measures. The difference in performance before and after simulation is compared using a t test. The investigators hypotheses that improved performance scores following the simulation based medical education would put the dot on the importance of simulation as a learning tool.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2012

Typical duration for not_applicable

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

March 1, 2012

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2014

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

March 17, 2016

Completed
12 days until next milestone

First Posted

Study publicly available on registry

March 29, 2016

Completed
Last Updated

March 30, 2016

Status Verified

March 1, 2016

Enrollment Period

2.3 years

First QC Date

March 17, 2016

Last Update Submit

March 29, 2016

Conditions

Keywords

High fidelity simulationSedationMedical education

Outcome Measures

Primary Outcomes (1)

  • Improved residents performance after simulation based education, measured by previously built performance grid

    3 to 6 months

Study Arms (2)

Simulation based sedation learning (Intervention Group)

EXPERIMENTAL

The program includes online learning. It is followed by development of interactive presentations, based on simulated cases or simulated patients (actors), low fidelity simulation for specific technical skills as well as high fidelity scenarios of complications related to sedation.

Other: SimulationDevice: Airway managementBehavioral: Crisis resource management

Control Group

NO INTERVENTION

Interventions

High fidelity simulation based sedation learning program

Simulation based sedation learning (Intervention Group)

Workshop on using airway management and oxygenation devices.

Simulation based sedation learning (Intervention Group)

Learning crisis resource management principles

Simulation based sedation learning (Intervention Group)

Eligibility Criteria

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

You may qualify if:

  • Residents from surgery programs, radiology, gastroenterology, pneumology, family medicine, emergency medicine of the University of Montreal
  • Residents with academic supervision with 1: 1 by a senior during their clinical practice

You may not qualify if:

  • Resident with prior instruction on sedation or advanced learning technical skills for airway management.
  • Refusal to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Evain JN, Do T, Harkouk H, Drolet P, Perron R, Georgescu M, Robitaille A, Tanoubi I. Mastering Sedation and Associated Respiratory Events through Simulation-Based Training: A Randomised Controlled Trial Involving Non-Anaesthesiology Residents. Eur J Investig Health Psychol Educ. 2024 Feb 23;14(3):463-473. doi: 10.3390/ejihpe14030031.

MeSH Terms

Interventions

Airway ManagementCrew Resource Management, Healthcare

Intervention Hierarchy (Ancestors)

TherapeuticsPatient Care ManagementHealth Services Administration

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
MD, Assistant Professor

Study Record Dates

First Submitted

March 17, 2016

First Posted

March 29, 2016

Study Start

March 1, 2012

Primary Completion

June 1, 2014

Study Completion

July 1, 2014

Last Updated

March 30, 2016

Record last verified: 2016-03