Simulation Training For Invasive Cardiovascular Procedures (Heart-SIMS1)

U

University of Coimbra

Status

Completed

Conditions

Coronary Artery Disease

Treatments

Behavioral: Simulation-based training

Study type

Interventional

Funder types

Other

Identifiers

NCT06224101
Heart-SIMS1

Details and patient eligibility

About

28 sixth-year medical students will attend a theoretical learning session on coronary angiography. After they will be randomized in 2 groups: a conventional training (CT) group (n=14) and a simulation training (ST) group (n=14). CT group will visualize a video-recorded simulation procedure with duration of 20 minutes, while ST group will perform CA simulated training with SimulHeart in groups of two also for 20 minutes. Finally, after the training session, students' knowledge will be assessed through a theoretical multiple-choice exam and a practical evaluation in a catheterization laboratory using SimulHeart.

Full description

The simulation protocol starts with a theoretical learning session on invasive coronary angiography (ICA) (1 hour), encompassing the learning objectives (coronary anatomy, procedural indications and safety considerations) for all participants. During the theoretical session, students will be instructed on the most utilized tools for conducting coronary catheterization, along with a step-by-step sequence of the procedure. Medical students will be then randomized to two training methodologies (1:1) using Python programming language, at the same location: a conventional training (CT) group (n=14) and a simulation training (ST) group (n=14). No pre-testing will be performed, because medical students, unlike residents, have limited knowledge on ICA, and randomization will naturally balance both groups. The CT group will visualize a video-recorded simulation procedure with duration of 20 minutes, in which the steps of the ICA are explained. The ST group will perform ICA simulated training with 3D printed simulator SimulHeart in groups of two, with debriefing and feedback. Participants will be taught on how to perform each step of the procedure and guide on safety measures concerning catheter handling, radiation exposure, and contrast administration. The duration of ICA simulated training will be 20 minutes per group. Both types of sessions will have the same instructions and duration (20 minutes). There will be time for questions and answers. After the training session, students' knowledge will be assessed through a theoretical multiple-choice exam, assessing basic coronary artery anatomy knowledge, procedural indications, and safety considerations (scored 0-100 points) and a practical evaluation. The practical evaluation will take place in a catheterization laboratory using SimulHeart simulator at "Unidade de Intervenção Cardiovascular (UNIC), Serviço de Cardiologia do Centro Hospitalar e Universitário de Coimbra (Coimbra, Portugal)". The participants will have to perform pre-specified steps during practical session of diagnostic ICA. The procedure will be video-taped and rated based on performance time, execution of pre-specified steps and monitoring of safety requirements. The student's performance will be evaluated (scored 0-100 points) in real-time and subsequently through review and the analysis of the recorded videos by experts interventionalists, blinded to the randomization and under a checklist of pre-specified safety endpoints and a performance evaluation checklist.

Enrollment

29 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • 6th-year medical students who have read and signed the informed consent

Exclusion criteria

  • Pregnant students
  • Previous experience in interventional cardiology

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

29 participants in 2 patient groups

Conventional training group
No Intervention group
Description:
The conventional training group will visualize a video-recorded simulation procedure with duration of 20 minutes, in which the steps of the ICA are explained.
Simulation training group
Experimental group
Description:
The simulation training group will perform coronary angiography simulated training with 3D printed simulator SimulHeart in groups of two, with debriefing and feedback. Participants will be taught on how to perform each step of the procedure and guide on safety measures concerning catheter handling, radiation exposure, and contrast administration. The duration of simulated training will be 20 minutes per group.
Treatment:
Behavioral: Simulation-based training

Trial contacts and locations

1

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Central trial contact

Manuel Oliveira Santos, MD; Bárbara Lobo

Data sourced from clinicaltrials.gov

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