Trial Outcomes & Findings for Evaluation of a Simulation Based Workshop in an Anesthesia Residency Program (NCT NCT03545984)

Last Updated: 2019-08-06

Results Overview

The composite score is a continuous outcome varies between 0 and 16; 0 being the worst possible score and 16 the best possible score. Composite score received by a resident from a supervising anesthesiologist; validated scoring system based on Anesthetist's Nontechnical Skills (ANTS) Global Rating Scale. The hierarchical ANTS scoring system consists at the highest level of four basic skill categories, namely task management, team working, situation awareness, and decision making. These skill categories are further divided up into 16 skill elements and then each "element" is scored 0-1 and then all elements are summed for a total score of 0-16. The decision to report outcome in categories (Score 14-16, Score 11-13, Score 10 and below) instead of numeric contentious outcome was data driven and not represent any specified performance categories(i.e., "best performance", "good performance", "poor performance").

Recruitment status

COMPLETED

Study phase

Target enrollment

48 participants

Primary outcome timeframe

just after first CSF drainage catheter insertion and during 4-week vascular rotation; at least by the end of 4-week rotation

Results posted on

2019-08-06

Participant Flow

Several residents who were randomized were unable to complete the study because they did not participate in the management of patients undergoing open or endovascular aortic surgery that required CSF drainage catheter insertion during their rotation..

This educational randomized trial was conducted on residents and they were enrolled and randomized in two study groups (arms) corresponding to two educational methods. Patients were not considered enrolled in this study.

Participant milestones

Participant milestones
Measure	Simulation-based Training The simulation-based training during the first week of rotation involves step-by-step instructions on insertion of the CSF drainage catheter including aseptic technique, position of patient (lateral vs. sitting), site of insertion. The simulation training is done on a mannequin to simulate actual conditions. We plan to use a simulation model, which is basically a torso with the ability to palpate the back and spinous processes and use the epidural needle with loss of resistance technique with haptic feedback. The trainees would be able to actually perform the procedure on the manikin. Simulation-based learning: Simulation-based teaching involves using done on a mannequin to simulate actual conditions	Problem Based Learning The residents allocated to the non-simulation group (problem based learning) receives standard educational teaching in the form of a problem based learning discussion during the first week of rotation. interactive problem based learning: Standard teaching (problem based learning discussion) during cardiac/vascular rotation
Overall Study STARTED	24	24
Overall Study COMPLETED	13	15
Overall Study NOT COMPLETED	11	9

Reasons for withdrawal

Reasons for withdrawal
Measure	Simulation-based Training The simulation-based training during the first week of rotation involves step-by-step instructions on insertion of the CSF drainage catheter including aseptic technique, position of patient (lateral vs. sitting), site of insertion. The simulation training is done on a mannequin to simulate actual conditions. We plan to use a simulation model, which is basically a torso with the ability to palpate the back and spinous processes and use the epidural needle with loss of resistance technique with haptic feedback. The trainees would be able to actually perform the procedure on the manikin. Simulation-based learning: Simulation-based teaching involves using done on a mannequin to simulate actual conditions	Problem Based Learning The residents allocated to the non-simulation group (problem based learning) receives standard educational teaching in the form of a problem based learning discussion during the first week of rotation. interactive problem based learning: Standard teaching (problem based learning discussion) during cardiac/vascular rotation
Overall Study CSF cases not present during rotation	11	9

Baseline Characteristics

Evaluation of a Simulation Based Workshop in an Anesthesia Residency Program

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Simulation-based Training n=13 Participants The simulation-based training during the first week of rotation involves step-by-step instructions on insertion of the CSF drainage catheter including aseptic technique, position of patient (lateral vs. sitting), site of insertion. The simulation training is done on a mannequin to simulate actual conditions. We plan to use a simulation model, which is basically a torso with the ability to palpate the back and spinous processes and use the epidural needle with loss of resistance technique with haptic feedback. The trainees would be able to actually perform the procedure on the manikin. Simulation-based learning: Simulation-based teaching involves using done on a mannequin to simulate actual conditions	Problem Based Learning n=15 Participants The residents allocated to the non-simulation group (problem based learning) receives standard educational teaching in the form of a problem based learning discussion during the first week of rotation. interactive problem based learning: Standard teaching (problem based learning discussion) during cardiac/vascular rotation	Total n=28 Participants Total of all reporting groups
Age, Continuous	NA years STANDARD_DEVIATION NA • n=5 Participants	NA years STANDARD_DEVIATION NA • n=7 Participants	NA years STANDARD_DEVIATION NA • n=5 Participants
Sex: Female, Male Female	NA Participants n=5 Participants	NA Participants n=7 Participants	NA Participants n=5 Participants
Sex: Female, Male Male	NA Participants n=5 Participants	NA Participants n=7 Participants	NA Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	NA Participants n=5 Participants	NA Participants n=7 Participants	NA Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	NA Participants n=5 Participants	NA Participants n=7 Participants	NA Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	NA Participants n=5 Participants	NA Participants n=7 Participants	NA Participants n=5 Participants
Months of training as CA3	6.8 months STANDARD_DEVIATION 3.0 • n=5 Participants	6.3 months STANDARD_DEVIATION 3.4 • n=7 Participants	6.5 months STANDARD_DEVIATION 3.2 • n=5 Participants
Spinal Drain Placed in the past	3 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants

PRIMARY outcome

Timeframe: just after first CSF drainage catheter insertion and during 4-week vascular rotation; at least by the end of 4-week rotation

Outcome measures

Outcome measures
Measure	Simulation-based Training n=13 Participants The simulation-based training during the first week of rotation involves step-by-step instructions on insertion of the CSF drainage catheter including aseptic technique, position of patient (lateral vs. sitting), site of insertion. The simulation training is done on a mannequin to simulate actual conditions. We plan to use a simulation model, which is basically a torso with the ability to palpate the back and spinous processes and use the epidural needle with loss of resistance technique with haptic feedback. The trainees would be able to actually perform the procedure on the manikin. Simulation-based learning: Simulation-based teaching involves using done on a mannequin to simulate actual conditions	Problem Based Learning n=15 Participants The residents allocated to the non-simulation group (problem based learning) receives standard educational teaching in the form of a problem based learning discussion during the first week of rotation. interactive problem based learning: Standard teaching (problem based learning discussion) during cardiac/vascular rotation
Composite Staff Evaluation Score (Anesthetist's Nontechnical Skills Global Rating Scale) Score 14-16	10 Participants	11 Participants
Composite Staff Evaluation Score (Anesthetist's Nontechnical Skills Global Rating Scale) Score 11-13	2 Participants	4 Participants
Composite Staff Evaluation Score (Anesthetist's Nontechnical Skills Global Rating Scale) Score 10 and below	1 Participants	0 Participants

Adverse Events

Simulation-based Training

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Problem Based Learning

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Simulation-based Training n=13 participants at risk The simulation-based training during the first week of rotation involves step-by-step instructions on insertion of the CSF drainage catheter including aseptic technique, position of patient (lateral vs. sitting), site of insertion. The simulation training is done on a mannequin to simulate actual conditions. We plan to use a simulation model, which is basically a torso with the ability to palpate the back and spinous processes and use the epidural needle with loss of resistance technique with haptic feedback. The trainees would be able to actually perform the procedure on the manikin. Simulation-based learning: Simulation-based teaching involves using done on a mannequin to simulate actual conditions	Problem Based Learning n=15 participants at risk The residents allocated to the non-simulation group (problem based learning) receives standard educational teaching in the form of a problem based learning discussion during the first week of rotation. interactive problem based learning: Standard teaching (problem based learning discussion) during cardiac/vascular rotation
Injury, poisoning and procedural complications Bloody tinged CSF drainage in the postop period	7.7% 1/13 • Till patients' hospital discharge, an average of 3 days Adverse events collected during this study included complications occurring due to the placement of CSF drainage catheters. Adverse events might occur during or after CSF placement procedure and were recorded for residents (study subject) who performed the procedure; next, adverse events were summarized by two study groups.	13.3% 2/15 • Till patients' hospital discharge, an average of 3 days Adverse events collected during this study included complications occurring due to the placement of CSF drainage catheters. Adverse events might occur during or after CSF placement procedure and were recorded for residents (study subject) who performed the procedure; next, adverse events were summarized by two study groups.
Injury, poisoning and procedural complications Bloody tap during CSF catheter insertion	15.4% 2/13 • Till patients' hospital discharge, an average of 3 days Adverse events collected during this study included complications occurring due to the placement of CSF drainage catheters. Adverse events might occur during or after CSF placement procedure and were recorded for residents (study subject) who performed the procedure; next, adverse events were summarized by two study groups.	6.7% 1/15 • Till patients' hospital discharge, an average of 3 days Adverse events collected during this study included complications occurring due to the placement of CSF drainage catheters. Adverse events might occur during or after CSF placement procedure and were recorded for residents (study subject) who performed the procedure; next, adverse events were summarized by two study groups.
Injury, poisoning and procedural complications Spinal cord ischemia/new postoperative neurological deficits	7.7% 1/13 • Till patients' hospital discharge, an average of 3 days Adverse events collected during this study included complications occurring due to the placement of CSF drainage catheters. Adverse events might occur during or after CSF placement procedure and were recorded for residents (study subject) who performed the procedure; next, adverse events were summarized by two study groups.	0.00% 0/15 • Till patients' hospital discharge, an average of 3 days Adverse events collected during this study included complications occurring due to the placement of CSF drainage catheters. Adverse events might occur during or after CSF placement procedure and were recorded for residents (study subject) who performed the procedure; next, adverse events were summarized by two study groups.
Injury, poisoning and procedural complications Postoperative CNS infection/meningitis	0.00% 0/13 • Till patients' hospital discharge, an average of 3 days Adverse events collected during this study included complications occurring due to the placement of CSF drainage catheters. Adverse events might occur during or after CSF placement procedure and were recorded for residents (study subject) who performed the procedure; next, adverse events were summarized by two study groups.	0.00% 0/15 • Till patients' hospital discharge, an average of 3 days Adverse events collected during this study included complications occurring due to the placement of CSF drainage catheters. Adverse events might occur during or after CSF placement procedure and were recorded for residents (study subject) who performed the procedure; next, adverse events were summarized by two study groups.

Additional Information

Dr. Maged Argalious

Cleveland Clinic

Phone: +12164452064

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place