Evaluation of a Simulation Based Workshop in an Anesthesia Residency Program

• ClinicalTrials.gov Identifier: NCT03545984
• Recruitment Status: Completed
• First Posted: June 6, 2018
• Results First Posted: August 6, 2019
• Last Update Posted: August 6, 2019
• Sponsor: The Cleveland Clinic
• Information provided by (Responsible Party): Maged Argalious, MD, The Cleveland Clinic

• Study Type: Interventional
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single (Outcomes Assessor); Primary Purpose: Other
• Condition: Cerebrospinal Fluid Drainage Catheter
• Interventions: Other: Simulation-based learning; Other: interactive problem based learning
• Enrollment: 48

Participant Flow

Recruitment Details	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..
Pre-assignment Details	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.

Arm/Group Title	Simulation-based Training	Problem Based Learning
Arm/Group Description	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	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
Period Title: Overall Study
Started	24	24
Completed	13	15
Not Completed	11	9
Reason Not Completed
CSF cases not present during rotation	11	9

Baseline Characteristics

Arm/Group Title		Simulation-based Training	Problem Based Learning	Total
Arm/Group Description		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	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 of all reporting groups
Overall Number of Baseline Participants		13	15	28
Baseline Analysis Population Description		[Not Specified]
Age, Continuous; Mean (Standard Deviation); Unit of measure: Years
	Number Analyzed	13 participants	15 participants	28 participants
		NA [1] (NA)	NA [1] (NA)	NA [1] (NA)
		[1] The subjects of study - anesthesia residents. This data was not collected for anesthesia residents.
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	13 participants	15 participants	28 participants
	Female	NA [1]	NA [1]	NA [2]
	Male	NA [1]	NA [1]	NA [2]
		[1] The subjects of study - anesthesia residents. This data was not collected for anesthesia residents; [2] Total not calculated because data are not available (NA) in one or more arms.
Ethnicity (NIH/OMB); Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	13 participants	15 participants	28 participants
	Hispanic or Latino	NA [1]	NA [1]	NA [2]
	Not Hispanic or Latino	NA [1]	NA [1]	NA [2]
	Unknown or Not Reported	NA [1]	NA [1]	NA [2]
		[1] The study participants - anesthesia residents. This info not collected for study participants.; [2] Total not calculated because data are not available (NA) in one or more arms.
Months of training as CA3; Mean (Standard Deviation); Unit of measure: Months
	Number Analyzed	13 participants	15 participants	28 participants
		6.8 (3.0)	6.3 (3.4)	6.5 (3.2)
Spinal Drain Placed in the past; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	13 participants	15 participants	28 participants
		3 23.1%	2 13.3%	5 17.9%

Outcome Measures

1. Primary Outcome

Title	Composite Staff Evaluation Score (Anesthetist's Nontechnical Skills Global Rating Scale)
Description	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").
Time Frame	just after first CSF drainage catheter insertion and during 4-week vascular rotation; at least by the end of 4-week rotation

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Simulation-based Training	Problem Based Learning
Arm/Group Description:	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	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 Number of Participants Analyzed	13	15
Measure Type: Count of Participants; Unit of Measure: Participants
Score 14-16	10 76.9%	11 73.3%
Score 11-13	2 15.4%	4 26.7%
Score 10 and below	1 7.7%	0 0.0%

Adverse Events

Time Frame	Till patients' hospital discharge, an average of 3 days
Adverse Event Reporting Description	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.
Arm/Group Title	Simulation-based Training	Problem Based Learning
Arm/Group Description	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	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
All-Cause Mortality
	Simulation-based Training	Problem Based Learning
	Affected / at Risk (%)	Affected / at Risk (%)
Total	0/13 (0.00%)	0/15 (0.00%)
Serious Adverse Events
	Simulation-based Training	Problem Based Learning
	Affected / at Risk (%)	Affected / at Risk (%)
Total	0/13 (0.00%)	0/15 (0.00%)
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	0%
	Simulation-based Training	Problem Based Learning
	Affected / at Risk (%)	Affected / at Risk (%)
Total	4/13 (30.77%)	3/15 (20.00%)
Injury, poisoning and procedural complications
Bloody tinged CSF drainage in the postop period †	1/13 (7.69%)	2/15 (13.33%)
Bloody tap during CSF catheter insertion †	2/13 (15.38%)	1/15 (6.67%)
Spinal cord ischemia/new postoperative neurological deficits †	1/13 (7.69%)	0/15 (0.00%)
Postoperative CNS infection/meningitis †	0/13 (0.00%)	0/15 (0.00%)
† Indicates events were collected by systematic assessment

Limitations and Caveats

Many of the residents who were randomized in the study did not participate in the care of patients requiring cerebrospinal fluid drainage catheters.

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

Results Point of Contact

• Name/Title: Dr. Maged Argalious
• Organization: Cleveland Clinic
• Phone: +12164452064
• EMail: ARGALIM@ccf.org

• Responsible Party: Maged Argalious, MD, The Cleveland Clinic
• ClinicalTrials.gov Identifier: NCT03545984
• Other Study ID Numbers: 14-613
• First Submitted: May 2, 2018
• First Posted: June 6, 2018
• Results First Submitted: February 1, 2019
• Results First Posted: August 6, 2019
• Last Update Posted: August 6, 2019