An interventional study of Wet lab tasks in Robotic Cardiac Surgery Simulation, sponsored by Aalborg University Hospital. Completed at 1 site in Denmark. Per ClinicalTrials.gov, last updated 2025-02-26.
Sponsored by Aalborg University Hospital · Not applicable, Interventional, and Other
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.
Aalborg University Hospital is the lead sponsor of 195 studies on the registry; 39 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Procedure: Wet lab tasks
Procedure: Wet lab tasks
Procedure: Wet lab tasks
Robotic-assisted internal thoracic artery harvesting, mitral annulus sutures placement and atrial closure in porcine model
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
Time frame: 6 months
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.
Time frame: 6 months
| Milestone | Experienced Robotic Cardiac Surgeons | Cardiac Surgeons With Limited Robotic Experience | Non-cardiac Surgeons With Limited Robotic Experience |
|---|---|---|---|
| Started | 4 | 7 | 8 |
| Completed | 4 | 7 | 8 |
| Not completed | 0 | 0 | 0 |
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
| score on a scale | Experienced Robotic Cardiac Surgeons | Cardiac Surgeons With Limited Robotic Experience | Non-cardiac Surgeons With Limited Robotic Experience |
|---|---|---|---|
| Time-based Score | 553 ± 47 | 127 ± 171 | 143 ± 181 |
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.
| score on a scale | Experienced Robotic Cardiac Surgeons | Cardiac Surgeons With Limited Robotic Experience | Non-cardiac Surgeons With Limited Robotic Experience |
|---|---|---|---|
| Modified Global Evaluative Assessment of Robotic Skills (mGEARS) | 20 ± 5 | 13 ± 2 | 11 ± 3 |
Collected over 6 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Experienced Robotic Cardiac Surgeons | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) |
| Cardiac Surgeons With Limited Robotic Experience | 0/7 (0%) | 0/7 (0%) | 0/7 (0%) |
| Non-cardiac Surgeons With Limited Robotic Experience | 0/8 (0%) | 0/8 (0%) | 0/8 (0%) |
| Age, Categorical(Participants) | Experienced Robotic Cardiac Surgeons | Cardiac Surgeons With Limited Robotic Experience | Non-cardiac Surgeons With Limited Robotic Experience | Total |
|---|---|---|---|---|
| <=18 years | 0 | 0 | 0 | 0 |
| Between 18 and 65 years | 4 | 6 | 7 | 17 |
| >=65 years | 0 | 1 | 1 | 2 |
| Age, Continuous(years) | Experienced Robotic Cardiac Surgeons | Cardiac Surgeons With Limited Robotic Experience | Non-cardiac Surgeons With Limited Robotic Experience | Total |
|---|---|---|---|---|
| Median | 44 (42 to 53) | 55 (43 to 63) | 42 (36 to 48) | 45 (42 to 55) |
| Sex: Female, Male(Participants) | Experienced Robotic Cardiac Surgeons | Cardiac Surgeons With Limited Robotic Experience | Non-cardiac Surgeons With Limited Robotic Experience | Total |
|---|---|---|---|---|
| Female | 0 | 2 | 3 | 5 |
| Male | 4 | 5 | 5 | 14 |
| Race and Ethnicity Not Collected(Participants) | Experienced Robotic Cardiac Surgeons | Cardiac Surgeons With Limited Robotic Experience | Non-cardiac Surgeons With Limited Robotic Experience | Total |
|---|---|---|---|---|
| Count of participants | — | — | — | 0 |
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Aalborg University Hospital