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Completed

NCT Number: NCT06224101

Simulation Training For Invasive Cardiovascular Procedures

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centro Hospitalar e Universitário de Coimbra

Coimbra, 3000-075, Portugal

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

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

Exclusion criteria

  • Pregnant students
  • Previous experience in interventional cardiology

Treatment and study plan

simulation-based training

Behavioral

simulation training consists of practicing diagnostic coronary angiography with 3D printed simulator-SimulHeart.

Primary outcomes

  1. Score of theoretical multiple-choice exam

    Time frame: 2 days

    Students' knowledge of both groups will be assessed through a theoretical multiple-choice exam, assessing basic coronary artery anatomy knowledge, procedural indications, and safety considerations (scored 0-100 points)

  2. Score of pratical evaluation of simulated coronary angiography in a catheterization laboratory

    Time frame: 2 days

    Students' knowledge of both groups will be assessed through a practical evaluation in a catheterization laboratory using 3D-simulator SimulHeart. The students will have to performe pre-specified steps during pratical session (scored 0-100 points)

  3. Final performance score (0-200 points)

    Time frame: 2 days

    Composite endpoint resulting from the sum of the practical evaluation score and the multiple-choice theoretical test score

Sponsors and collaborators

Lead sponsor

University of Coimbra

Other

Registry information

Official study title

Heart-SIMS1: Simulation Training For Invasive Cardiovascular Procedures

Acronym: Heart-SIMS1

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jan 25, 2024
Registry last updated
Jun 11, 2024

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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