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Evaluation of a Simulation Based Workshop in an Anesthesia Residency Program

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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:
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
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
Hide 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
Arm/Group Title Simulation-based Training Problem Based Learning Total
Hide 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
Hide 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%
1.Primary Outcome
Title Composite Staff Evaluation Score (Anesthetist's Nontechnical Skills Global Rating Scale)
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Simulation-based Training Problem Based Learning
Hide 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%
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
Hide 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%) 
Hide Serious Adverse Events
Simulation-based Training Problem Based Learning
Affected / at Risk (%) Affected / at Risk (%)
Total   0/13 (0.00%)   0/15 (0.00%) 
Hide 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
Many of the residents who were randomized in the study did not participate in the care of patients requiring cerebrospinal fluid drainage catheters.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Maged Argalious
Organization: Cleveland Clinic
Phone: +12164452064
EMail: ARGALIM@ccf.org
Layout table for additonal information
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