Robotic Cardiac Surgery Wet Lab Simulation Study

Validity Evidence for Simulation-based Assessment of Robotic Cardiac Surgical Skills and Examination of Learning Curves in Wet Labs

The goal of this study is to investigate validity of the wet lab robotic cardiac surgery model used for training in robotic cardiac surgery and to evaluate learning curves in trainees of different surgical specialities. The investigators hope to recruit experienced robotic cardiac surgeons (experts) and cardiac and non-cardiac surgeons with minimal robotic experience (trainees). Participants will perform three predetermined tasks common in the wet lab robotic cardiac surgery training. Participants will be evaluated at baseline for each task. From experts' performance the mastery learning level will be calculated. Trainees will perform the tasks until mastery is achieved. The investigators will then be able to evaluate validity of the wet lab model and analyze learning curves in all participants by rating their performance.

Study Overview

• Status: Completed
• Conditions: Robotic Cardiac Surgery Simulation
• Intervention / Treatment: Procedure: Wet lab tasks

• Study Type: Interventional
• Enrollment (Actual): 19
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Aalborg, Denmark, 9000
    • Aalborg University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Experienced robotic cardiac surgeons: robotic surgeons with total volume > 50 robotic cardiac operations and at least 20 robotic cases annually
• Cardiac surgeons with limited robotic experience (robotic novices): on-going or completed cardio-thoracic residency
• Non-cardiac surgeons with limited robotic experience (robotic novices): on-going or completed surgical specialty residency (general surgery, urology, gynaecology, ENT surgery)

Exclusion Criteria:

• Robotic novices with > 5 hours experience of any robotic system

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Experienced robotic cardiac surgeons	Procedure: Wet lab tasks; Robotic-assisted internal thoracic artery harvesting, mitral annulus sutures placement and atrial closure in porcine model
Active Comparator: Cardiac surgeons with limited robotic experience	Procedure: Wet lab tasks; Robotic-assisted internal thoracic artery harvesting, mitral annulus sutures placement and atrial closure in porcine model
Active Comparator: Non-cardiac surgeons with limited robotic experience	Procedure: Wet lab tasks; Robotic-assisted internal thoracic artery harvesting, mitral annulus sutures placement and atrial closure in porcine model

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time-based Score	The time-based score (TBS) was calculated as follows: TBS = maximal total training time per task - actual completion time - errors. Units of measure - seconds. Minimum score 0, Maximum score 1222. TBS was calculated in seconds, where 0 was the lowest score and a higher number indicated a faster time to perform the task. The score range	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Modified Global Evaluative Assessment of Robotic Skills (mGEARS)	In modified Global Evaluative Assessment of Robotic Skills (mGEARS) the tasks were not rated on autonomy domain as autonomy could not be evaluated from recordings. The mGEARS score was used to evaluate the overall robotic proficiency by 5 domains: depth perception, bimanual dexterity, efficiency, force sensitivity, and robotic control. The score ranged from 5 to 25, where 5 and 25 indicated the least and most proficient performance, respectively.	6 months

Collaborators and Investigators

• Sponsor: Aalborg University Hospital
• Investigators: Principal Investigator: Gennady V Atroshchenko, MD, Aalborg University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2021
• Primary Completion (Actual): February 28, 2022
• Study Completion (Actual): February 28, 2022

Study Registration Dates

• First Submitted: September 1, 2021
• First Submitted That Met QC Criteria: September 9, 2021
• First Posted (Actual): September 13, 2021

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 5, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: Robotic Cardiac Surgery; Wet Lab Simulation
• Other Study ID Numbers: 2020-000992-55

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No