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The goal of this clinical trial is to learn if simulator-based training will improve interventional cardiology fellows' skills and will improve patient outcomes.
The main questions it aims to answer are:
Interventional cardiology fellows in their first year of training will be randomized between standard master-apprentice training or simulator-based training before starting their cath lab period.
They will be supervised during their cath lab period as first operators by senior interventional cardiologists.
During their first 50 procedures performed as supervised first operator, specific procedural data will be collected.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Simulator-based training group | Experimental | Interventional cardiology fellows will undergo a two-day training program on high-fidelity simulators |
|
| Standard group | Active Comparator | Interventional cardiology fellows will undergo standard training based on master-apprentice model |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Simulator-based training | Procedure | A two-day training program will be performed before starting their cath lab period as interventional cardiology fellows |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean total fluoroscopy radiation time (expressed in seconds) | Difference in Mean total fluoroscopy radiation time, during the periods where the cardiology fellows act as primary operators, between groups | End of procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Mean arterial cannulation time (expressed in seconds) | Difference in mean coronary cannulation time is considered as the time from sheath insertion to first right and left selective coronary angiography obtained (expressed in minutes) | End of procedure |
| Total radiation dose (expressed in cGy*cm2) |
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Inclusion Criteria:
Exclusion Criteria:
Specializing doctors:
Patients:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| FRANCESCO Burzotta, Prof.. | Contact | +393494295290 | francesco.burzotta@policlinicogemelli.it |
| Name | Affiliation | Role |
|---|---|---|
| Francesco Burzotta, Prof | Fondazione Policlinico Universitario Agostino Gemelli IRCCS | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fondazione Policlinico Univrsitario Agostino Gemelli IRCCS | Rome | 00168 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27397459 | Background | Aggarwal S, Choudhury E, Ladha S, Kapoor PM, Kiran U. Simulation in cardiac catheterization laboratory: Need of the hour to improve the clinical skills. Ann Card Anaesth. 2016 Jul-Sep;19(3):521-6. doi: 10.4103/0971-9784.185548. | |
| 33419690 | Background | Pezel T, Coisne A, Bonnet G, Martins RP, Adjedj J, Biere L, Lattuca B, Turpeau S, Popovic B, Ivanes F, Lafitte S, Deharo JC, Bernard A. Simulation-based training in cardiology: State-of-the-art review from the French Commission of Simulation Teaching (Commission d'enseignement par simulation-COMSI) of the French Society of Cardiology. Arch Cardiovasc Dis. 2021 Jan;114(1):73-84. doi: 10.1016/j.acvd.2020.10.004. Epub 2021 Jan 5. |
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| Standard training | Procedure | Standard master-apprentice training interventional cardiology fellows' program during their cath lab period |
|
Difference in total radiation dose adsorbed by patients as evaluated by dose-area product (DAP) (expressed in Gycm2) |
| End of procedure |
| Total contrast dose (expressed in ml) | Difference in total contrast dose administered to the patients | End of procedure |
| Failure to achieve arterial cannulation (e.g.: rate of failure for each partecipant) | Difference in failure to achieve arterial cannulation | End of procedure |
| Failure to achieve right coronary cannulation (e.g.: rate of failure for each partecipant) | Difference in failure to achieve right coronary cannulation | End of procedure |
| Failure to achieve left coronary cannulation (e.g.: rate of failure for each partecipant) | Difference in failure to achieve left coronary cannulation | End of procedure |
| Number of catheters used | Difference in number of catheters used to complete the diagnostic procedure | End of procedure |
| Any major or minor procedural and clinical complication | Difference in any major or minor complication occurred during the procedure or the index hospitalization | Up to the end of index hospitalization or date of death from any cause (we collect any kind of clinical or procedural complication occuring during the determined period) |
| 21530937 | Background | Sciahbasi A, Romagnoli E, Trani C, Burzotta F, Pendenza G, Tommasino A, Leone AM, Niccoli G, Porto I, Penco M, Lioy E. Evaluation of the "learning curve" for left and right radial approach during percutaneous coronary procedures. Am J Cardiol. 2011 Jul 15;108(2):185-8. doi: 10.1016/j.amjcard.2011.03.022. Epub 2011 Apr 29. |
| 29588710 | Background | Joshi A, Wragg A. Simulator Training in Interventional Cardiology. Interv Cardiol. 2016 May;11(1):70-73. doi: 10.15420/icr.2016.11.1.70. |
| 30732853 | Background | Popovic B, Pinelli S, Albuisson E, Metzdorf PA, Mourer B, Tran N, Camenzind E. The Simulation Training in Coronary Angiography and Its Impact on Real Life Conduct in the Catheterization Laboratory. Am J Cardiol. 2019 Apr 15;123(8):1208-1213. doi: 10.1016/j.amjcard.2019.01.032. Epub 2019 Jan 24. |
| 26671629 | Background | Voelker W, Petri N, Tonissen C, Stork S, Birkemeyer R, Kaiser E, Oberhoff M. Does Simulation-Based Training Improve Procedural Skills of Beginners in Interventional Cardiology?--A Stratified Randomized Study. J Interv Cardiol. 2016 Feb;29(1):75-82. doi: 10.1111/joic.12257. Epub 2015 Dec 16. |
| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |