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Evaluation of a Simulation Based Workshop in an Anesthesia Residency Program

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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

Tracking Information
First Submitted Date  ICMJE May 2, 2018
First Posted Date  ICMJE June 6, 2018
Results First Submitted Date  ICMJE February 1, 2019
Results First Posted Date  ICMJE August 6, 2019
Last Update Posted Date August 6, 2019
Actual Study Start Date  ICMJE June 5, 2014
Actual Primary Completion Date June 5, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 7, 2019)
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").
Original Primary Outcome Measures  ICMJE
 (submitted: June 1, 2018)
Composite score (Anesthetist's Nontechnical Skills Global Rating Scale) [ Time Frame: just after first CSF drainage catheter insertion and management during 4-week vascular rotation; at least by the end of 4-week rotation ]
The composite score 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. Each element is anchored for rating with examples of behaviors indicating good and poor practice.
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Evaluation of a Simulation Based Workshop in an Anesthesia Residency Program
Official Title  ICMJE Evaluation of a Simulation Based Workshop to Enhance Learning of Insertion and Management of CSF Drainage Catheters in an Anesthesia Residency Program
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE Cerebrospinal Fluid Drainage Catheter
Intervention  ICMJE
  • Other: Simulation-based learning
    Simulation-based teaching involves using done on a mannequin to simulate actual conditions
    Other Name: Simulation
  • Other: interactive problem based learning
    Standard teaching (problem based learning discussion) during cardiac/vascular rotation
    Other Name: PBL
Study Arms  ICMJE
  • 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.
    Intervention: Other: Simulation-based learning
  • 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.
    Intervention: Other: interactive problem based learning
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 7, 2019)
48
Original Estimated Enrollment  ICMJE
 (submitted: June 1, 2018)
40
Actual Study Completion Date  ICMJE July 25, 2018
Actual Primary Completion Date June 5, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 99 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03545984
Other Study ID Numbers  ICMJE 14-613
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Maged Argalious, MD, The Cleveland Clinic
Study Sponsor  ICMJE The Cleveland Clinic
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Maged Argalious, MD The Cleveland Clinic
PRS Account The Cleveland Clinic
Verification Date June 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP