Robotic Cardiac Surgery Wet Lab Simulation Study

• Sponsor: Aalborg University Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT05043064
• Collaborator: (none)
• Enrollment: 19
• Location: 1
• Arms: 3
• Actual Duration (Months): 3.1
• Patients Per Site Per Month: 6.2

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Robotic Cardiac Surgery Simulation	Procedure: Wet lab tasks	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 19 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Masking Description: All tasks will be recorded and evaluated blinded using the modified Global Evaluative Assessment of Robotic Skills (mGEARS) score by two not participating raters
• Primary Purpose: Other
• Official Title: Validity Evidence for Simulation-based Assessment of Robotic Cardiac Surgical Skills and Examination of Learning Curves in Wet Labs
• Actual Study Start Date: Sep 1, 2021
• Actual Primary Completion Date: Dec 3, 2021
• Actual Study Completion Date: Dec 3, 2021

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Time-based score [4 months]

   Time-based scoring equation will be calculated as follows: Score = Max time - Completion time - Errors Max time is the total time that an individual will be allowed to complete the task during the base-line performance. Completion time is either; The mean time for completion of each expert's last 2 attempts which will be used to calculate the mastery learning level based on the formula above The time taken by each study participant to complete the task Errors will be divided in minor and major ones. A minor error will result in adding a 10 second penalty time to the time-based score equation. A major error will result in a score of zero, regardless of time to completion. Minor errors: moving robotic arms out of view robotic arm collision drop of the needle Major errors: avulsion of ITA or suturing model tearing/ fraying the suture gross tissue damage (specifically with the cautery)

Secondary Outcome Measures

1. modified Global Evaluative Assessment of Robotic Skills (mGEARS) [4 months]

   In mGEARS score the tasks will not be rated on autonomy domain as autonomy cannot be evaluated from recordings. A total score range from 5-25, where higher scores mean a better overall technical proficiency for robotic surgery.

2. Learning curves for each task [4 months]

   the training time to reach the mastery learning level for the surgeons with limited robotic experience; both total time and for each task

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Aalborg University Hospital	Aalborg		Denmark	9000

Sponsors and Collaborators

• Aalborg University Hospital

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Gennady Atroshchenko, Principal Investigator, Aalborg University Hospital
• ClinicalTrials.gov Identifier: NCT05043064
• Other Study ID Numbers: 2020-000992-55
• First Posted: Sep 13, 2021
• Last Update Posted: Dec 7, 2021
• Last Verified: Dec 1, 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Gennady Atroshchenko, Principal Investigator, Aalborg University Hospital: Robotic Cardiac Surgery; Wet Lab Simulation

Study Results

No Results Posted as of Dec 7, 2021