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

Brief Summary:
The study aim is to determine whether simulation based learning would improve senior anesthesiology residents' patient care performance during the insertion and management of cerebrospinal fluid drainage catheters when compared to interactive problem based learning (PBL) using the Anesthetist's Nontechnical Skills Global rating scale

Condition or disease Intervention/treatment Phase
Cerebrospinal Fluid Drainage Catheter Other: Simulation-based learning Other: interactive problem based learning Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Prospective randomized educational trial
Masking: Single (Outcomes Assessor)
Masking Description: The staff anesthesiologist evaluating a resident on spinal drain placement would NOT be aware of the resident's group allocation.
Primary Purpose: Other
Official Title: Evaluation of a Simulation Based Workshop to Enhance Learning of Insertion and Management of CSF Drainage Catheters in an Anesthesia Residency Program
Actual Study Start Date : June 5, 2014
Actual Primary Completion Date : June 5, 2017
Actual Study Completion Date : July 25, 2018

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: 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.
Other: Simulation-based learning
Simulation-based teaching involves using done on a mannequin to simulate actual conditions
Other Name: Simulation

Active Comparator: 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.
Other: interactive problem based learning
Standard teaching (problem based learning discussion) during cardiac/vascular rotation
Other Name: PBL

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Anesthesia residents in their CA-2 or CA-3 year in the vascular rotation who would need to monitor and take care of these systems as well as perform lumbar CSF drainage in the operating room (for thoracic aortic vascular procedures-open and endovascular) or cardiovascular ICU.

Exclusion Criteria:

  • Anesthesia residents who already were enrolled in the study during their previous vascular rotation

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03545984

Sponsors and Collaborators
The Cleveland Clinic
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Principal Investigator: Maged Argalious, MD The Cleveland Clinic
  Study Documents (Full-Text)

Documents provided by Maged Argalious, MD, The Cleveland Clinic:
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Responsible Party: Maged Argalious, MD, Principal Investigator, The Cleveland Clinic Identifier: NCT03545984    
Other Study ID Numbers: 14-613
First Posted: June 6, 2018    Key Record Dates
Results First Posted: August 6, 2019
Last Update Posted: August 6, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Cerebrospinal Fluid Leak
Neurologic Manifestations
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries