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Evaluation of a Simulation Based Workshop in an Anesthesia Residency Program

Primary Purpose

Cerebrospinal Fluid Drainage Catheter

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Simulation-based learning
interactive problem based learning
Sponsored by
The Cleveland Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Cerebrospinal Fluid Drainage Catheter

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    simulation-based training

    problem based learning

    Arm 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.

    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.

    Outcomes

    Primary Outcome Measures

    Composite Staff Evaluation Score (Anesthetist's Nontechnical Skills Global Rating Scale)
    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").

    Secondary Outcome Measures

    Full Information

    First Posted
    May 2, 2018
    Last Updated
    June 7, 2019
    Sponsor
    The Cleveland Clinic
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03545984
    Brief Title
    Evaluation of a Simulation Based Workshop in an Anesthesia Residency Program
    Official Title
    Evaluation of a Simulation Based Workshop to Enhance Learning of Insertion and Management of CSF Drainage Catheters in an Anesthesia Residency Program
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2019
    Overall Recruitment Status
    Completed
    Study Start Date
    June 5, 2014 (Actual)
    Primary Completion Date
    June 5, 2017 (Actual)
    Study Completion Date
    July 25, 2018 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    The Cleveland Clinic

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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
    Detailed Description
    This prospective randomized trial allocates anesthesia residents into two educational groups and compares resident's performance on the the composite score (Anesthetist's Nontechnical Skills Global Rating Scale) assigned by supervising anesthesiologists after the insertion and management of cerebrospinal fluid drainage catheter during resident's vascular rotation. The senior residents (CA-3 and CA-2) rotating through the vascular rotation at the Cleveland Clinic main campus starting December 2014 are randomly allocated to simulation based learning versus problem based learning using computer generated randomization. Randomization occurs prior to the start of the vascular rotation. The randomization is designed to allocate all residents (usually one or 2 residents) rotating through the vascular rotation each month (4 week rotation) to either simulation or problem based learning. The learning activity (whether simulation based or problem based) is scheduled to occur in the first week of the vascular rotation and the content of the educational activities (simulation based and problem based) is designed to cover the same educational material. Two of the authors of the study moderate all educational activities interchangeably (simulation and problem based). Simulation based learning required advanced scheduling of activities with our simulation center to ensure space and equipment availability and is a key factor in the decision to perform the randomization in 4 month intervals rather than month to month. The primary outcome is the composite score (Anesthetist's Nontechnical Skills Global Rating Scale) received by participating residents during their first CSF drainage catheter insertion and management as evaluated by their supervising cardiothoracic anesthesiologists. Evaluating staff anesthesiologists is blinded to the residents' allocation group and were not involved in the study. Baseline and outcomes data are prospectively collected on participating residents and respective patients undergoing thoracic aortic vascular procedures requiring CSF drainage catheters at the Cleveland Clinic main campus during the study period. Complications of CSF drainage catheters is also collected by looking into the EPIC of all the patients who had CSF drainage catheters handled by the residents in the study. Patients are followed up till they leave the hospital to evaluate if they developed any complications like paraplegia, infection, retained fragments. This will be a secondary descriptive outcome. The simulation scenario consists of a patient requiring perioperative CSF drainage prior to undergoing thoracic aortic aneurysm surgery. The simulation 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. Various commercial CSF drainage kits are available. We will use the Medtronic lumbar drainage kit, which is available in the OR. Sterile technique, including chlorhexidine prep, full gown, sterile drape, sterile gloves, mask, hat. Insertion is typically at L3-L4 or L4-L5.The Tuohy needle will be inserted with the bevel facing cephalad in incremental fashion with loss of resistance technique until the epidural space is reached and then inserted further till a distinct pop is felt and the subarachnoid space entered. This will be confirmed by free flow of CSF from the Tuohy needle. The CSF catheter will then be inserted through the Tuohy needle, taking care to avoid marked seepage of CSF by minimizing the duration between trocar withdrawal and catheter introduction. The technique of using wire reinforced catheters as opposed to ordinary catheters will be demonstrated ( available on Integra CSF drainage catheters). The catheter will be threaded approximately 5 to 7 cm past the needle into the intrathecal space, the needle will be gently removed and the catheter secured with a clear occlusive dressing. Confirmation of free CSF drainage is obtained prior to dressing. The simulation would continue needing assembly and attachment of the catheter to the monitor through a transducer and learning how to drain the CSF at a particular preset value. 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Cerebrospinal Fluid Drainage Catheter

    7. Study Design

    Primary Purpose
    Other
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    Prospective randomized educational trial
    Masking
    Outcomes Assessor
    Masking Description
    The staff anesthesiologist evaluating a resident on spinal drain placement would NOT be aware of the resident's group allocation.
    Allocation
    Randomized
    Enrollment
    48 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    simulation-based training
    Arm Type
    Experimental
    Arm 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.
    Arm Title
    problem based learning
    Arm Type
    Active Comparator
    Arm Description
    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.
    Intervention Type
    Other
    Intervention Name(s)
    Simulation-based learning
    Other Intervention Name(s)
    Simulation
    Intervention Description
    Simulation-based teaching involves using done on a mannequin to simulate actual conditions
    Intervention Type
    Other
    Intervention Name(s)
    interactive problem based learning
    Other Intervention Name(s)
    PBL
    Intervention Description
    Standard teaching (problem based learning discussion) during cardiac/vascular rotation
    Primary Outcome Measure Information:
    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

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    99 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Maged Argalious, MD
    Organizational Affiliation
    The Cleveland Clinic
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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