COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC:

Get the latest research information from NIH: Menu

High Fidelity Simulation and Sedation Training of Non-anesthesiologists Residents (DedSim)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02722226
Recruitment Status : Completed
First Posted : March 29, 2016
Last Update Posted : March 30, 2016
Information provided by (Responsible Party):
Issam Tanoubi, Université de Montréal

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.

Condition or disease Intervention/treatment Phase
Performance of Non-anesthesiologists Residents for the Management of Sedation's Complications Other: Simulation Device: Airway management Behavioral: Crisis resource management Not Applicable

Show Show detailed description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: The Impact of a High Fidelity Simulation Based Sedation Training on the Performance of Non-anesthesiologists Residents for the Management of Complications Associated to Sedation.
Study Start Date : March 2012
Actual Primary Completion Date : June 2014
Actual Study Completion Date : July 2014

Arm Intervention/treatment
Experimental: Simulation based sedation learning (Intervention Group)
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: Simulation
High fidelity simulation based sedation learning program

Device: Airway management
Workshop on using airway management and oxygenation devices.

Behavioral: Crisis resource management
Learning crisis resource management principles

No Intervention: Control Group

Primary Outcome Measures :
  1. Improved residents performance after simulation based education, measured by previously built performance grid [ Time Frame: 3 to 6 months ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Resident with prior instruction on sedation or advanced learning technical skills for airway management.
  • Refusal to participate
Layout table for additonal information
Responsible Party: Issam Tanoubi, MD, Assistant Professor, Université de Montréal Identifier: NCT02722226    
Other Study ID Numbers: SedSim1
First Posted: March 29, 2016    Key Record Dates
Last Update Posted: March 30, 2016
Last Verified: March 2016
Keywords provided by Issam Tanoubi, Université de Montréal:
High fidelity simulation
Medical education