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Completed

NCT Number: NCT02483546

High Fidelity Simulation vs Standard Teaching Training of Cardiac Resuscitation

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 .

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Key information

Conditions

Cardiac Arrest Cardiovascular Diseases Heart Arrest Heart Diseases

Age range

18 year–30 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

university of Monastir

Monastir, Monastir Governorate, 5000, Tunisia

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Medecine students

Exclusion criteria

  • Non Medecine students

Treatment and study plan

Laerdal®

Device

simulation- based educational intervention

huma patient based training

Behavioral

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

Behavioral

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.

Primary outcomes

  1. better acquisition of cognitive skills for students

    Time frame: just after randomisation (one day)

    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.

Secondary outcomes

  1. Satisfaction 5 point likert scale

    Time frame: just after randomisation (one day)

    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).

Sponsors and collaborators

Lead sponsor

University of Monastir

Other

Registry information

Official study title

High Fidelity Simulation In Medecine Education

Acronym: SIMCARE

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Jun 29, 2015
Registry last updated
Jun 20, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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