High Fidelity Simulation vs Standard Teaching Training of Cardiac Resuscitation

Cardiac Arrest Clinical Trial

— SIMCARE  

Official title:

High Fidelity Simulation In Medecine Education

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02483546
• Other study ID #: 12345
• Status: Completed
• Phase: N/A
• First received: February 20, 2015
• Last updated: June 17, 2016
• Start date: January 2014
• Est. completion date: September 2015

Study information

• Verified date: June 2016
• Source: University of Monastir
• Contact: n/a
• Is FDA regulated: No
• Health authority: Tunisia: Ministry of Public Health
• Study type: Interventional

Clinical Trial Summary

High fidelity Simulation has spread from anesthesiology to other disciplines such as internal medicine, pediatrics, and emergency medicine . Over the past decade, the use of simulation in medical education has increased exponentially. The term ''simulation'' spans a wide variety of formats, from the low-tech actor portraying a standardized patient to high-fidelity mannequin-based human patient simulation (HPS). HPS is able of both simulating realistic patient encounters and giving real-time, physiologically accurate feedback. Studies thus far show that use of simulation in training medical students and residents is helpful in strengthening students' knowledge and in evaluating their performance. Students appreciate simulation-based education as ''an opportunity to learn new skills in a safe environment .

Description:

This was a randomized, controlled trial of a simulation- based educational intervention designed to increase medicine student's clinical skills in cardiac arrest procedures .The investigators included 181 fifth-year medical students rotating in the emergency department of Fattouma Bourguiba University hospital of Monastir (Tunisia) during the period from January 2013 to January 2014.Students were randomized into two groups using a random number generator to an intervention group (simulatortrained, n = 99) or a control group (traditionally teaching, n =82).

The investigators conducted a prospective, randomized, non-blinded study to determine whether simulation based training is superior to traditional teaching in the assessment and management of simulated patients presenting with myocardial infarction (MI) complicated by ventricular fibrillation.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 181
• Est. completion date: September 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 30 Years

Eligibility

Inclusion Criteria:

• Medecine students

Exclusion Criteria:

• Non Medecine students

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Cardiac Arrest
• Heart Arrest

Intervention

Device:
• Laerdal®
simulation- based educational intervention

Behavioral:
• huma patient based training
Students randomized to receive simulation training .The mannequin Siman 3G laerdal® displays multiple physiologic and pharmacologic responses. Three volunteers were involved in the scenario while the others were observers through an audiovisual projection. Students participating in the scenario were given 15 minutes to evaluate and manage a 60-year-old man with a known history of coronary artery disease and diabetes who presented to the emergency department with chest pain revealing an acute ST elevation myocardial infarction complicated by ventricular fibrillation. Students were required to recognize and manage ventricular fibrillation when the patient became pulseless and unresponsive. After performing the simulation, the entire group was convened for debriefing of the case.
• traditionally teaching
Control group students received a traditional course using slides during 60 minutes about the management of cardio pulmonary resuscitation according to the latest recommendations of the AHA. This course is offered by the same trainer who participated in the simulation session. Students were free to ask questions as the progress of education. The same educational objectives were treated with the two groups.

Locations

Country	Name	City	State
Tunisia	university of Monastir	Monastir

Sponsors (1)

Lead Sponsor	Collaborator
University of Monastir

Country where clinical trial is conducted

Tunisia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	better acquisition of cognitive skills for students	Pretest using 20 multiple choice questions after randomization. A second round of the same testing was then conducted for both groups just after the course (posttest). The test score range from 0 to 20 (maximum). The difference between the rating of the post-test and pre-test identifies the delta score of the student.	just after randomisation (one day)	Yes
Secondary	Satisfaction 5 point likert scale	Students rated their satisfaction level with a 5 point likert scale framed as attitude toward simulation compared with control group: dissatisfied (1 point), fairly satisfied (2 points), neither satisfied (3points), satisfied (4 points), and very satisfied (5 points).	just after randomisation (one day)	Yes