CClinicalTrials.gg
CompletedNCT03545984Updated Aug 6, 2019Results posted

Evaluation of a Simulation Based Workshop in an Anesthesia Residency Program

An interventional study of Simulation-based learning and interactive problem based learning in Cerebrospinal Fluid Drainage Catheter, sponsored by The Cleveland Clinic. Completed. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2019-08-06.

Sponsored by The Cleveland Clinic · Not applicable, Interventional, and Other

From the registry’s dates

  • Registered 3 years 10 months after the study started (first participant enrolled Jun 2014, registered May 2018).
Phase
Not applicable
Study type
Interventional
Enrollment
48
Allocation
Randomized
Ages
18 Years to 99 Years
Sex
All
01

Study 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

Read the 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.

02

Conditions studied

  • Cerebrospinal Fluid Drainage Catheter
03

In context

Cerebrospinal Fluid Leak

45 studies on the registry are indexed under Cerebrospinal Fluid Leak; 10 are open to participants now.

This study's enrollment of 48 is below the median of 68 across 27 interventional studies indexed under Cerebrospinal Fluid Leak.

Browse Cerebrospinal Fluid Leak studies →

Lead sponsor

The Cleveland Clinic is the lead sponsor of 818 studies on the registry; 118 are open to participants now.

Of its 89 completed or terminated interventional studies of FDA-regulated products, 72 (81%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 99 Years
Sexes eligible
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

Exclusion Criteria:

  • Anesthesia residents who already were enrolled in the study during their previous vascular rotation
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
48 participants (actual)

Study arms

  • 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

  • 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

Interventions

  • OtherSimulation-based learning

    Simulation-based teaching involves using done on a mannequin to simulate actual conditions

    Also known as: Simulation

  • Otherinteractive problem based learning

    Standard teaching (problem based learning discussion) during cardiac/vascular rotation

    Also known as: PBL

06

What researchers measure

Primary outcomes

  1. 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").

    Time frame: just after first CSF drainage catheter insertion and during 4-week vascular rotation; at least by the end of 4-week rotation

07

Results

Posted Aug 6, 2019
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.

Participant flow

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..

Participant flow — Overall Study
MilestoneSimulation-based TrainingProblem Based Learning
Started2424
Completed1315
Not completed119
Withdrew: Csf cases not present during rotation119

Outcome measures

PrimaryComposite 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").

Time frame:
just after first CSF drainage catheter insertion and during 4-week vascular rotation; at least by the end of 4-week rotation
Reported as:
Count of participants · Participants
Composite Staff Evaluation Score (Anesthetist's Nontechnical Skills Global Rating Scale)
ParticipantsSimulation-based TrainingProblem Based Learning
Score 14-161011
Score 11-1324
Score 10 and below10

Adverse events

Collected over Till patients' hospital discharge, an average of 3 days. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Simulation-based Training0/13 (0%)0/13 (0%)4/13 (30.8%)
Problem Based Learning0/15 (0%)0/15 (0%)3/15 (20%)
Most frequent other events
Most frequent other events
EventSimulation-based TrainingProblem Based Learning
Bloody tap during CSF catheter insertionInjury, poisoning and procedural complications2/131/15
Bloody tinged CSF drainage in the postop periodInjury, poisoning and procedural complications1/132/15
Spinal cord ischemia/new postoperative neurological deficitsInjury, poisoning and procedural complications1/130/15
Postoperative CNS infection/meningitisInjury, poisoning and procedural complications0/130/15

Baseline characteristics

Age, Continuous
Age, Continuous(years)Simulation-based TrainingProblem Based LearningTotal
MeanNA ± NANA ± NANA ± NA
Sex: Female, Male
Sex: Female, Male(Participants)Simulation-based TrainingProblem Based LearningTotal
FemaleNANANA
MaleNANANA
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Simulation-based TrainingProblem Based LearningTotal
Hispanic or LatinoNANANA
Not Hispanic or LatinoNANANA
Unknown or Not ReportedNANANA
Months of training as CA3
Months of training as CA3(months)Simulation-based TrainingProblem Based LearningTotal
Mean6.8 ± 3.06.3 ± 3.46.5 ± 3.2
Spinal Drain Placed in the past
Spinal Drain Placed in the past(Participants)Simulation-based TrainingProblem Based LearningTotal
Count of participants325
08

Study locations

No study locations are listed for this record.

09

References and documents

Study documents

  • Protocol and statistical analysis plan · Feb 11, 2014

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 6, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT03545984
Lead sponsor
The Cleveland Clinic
Responsible party
Maged Argalious, MD (Principal Investigator, The Cleveland Clinic) — Principal investigator
First posted
Jun 6, 2018
Start date
Jun 5, 2014
Primary completion
Jun 5, 2017
Completion
Jul 25, 2018
Results posted
Aug 6, 2019
Last update
Aug 6, 2019

Study contacts

Maged Argalious, MD
principal investigator · The Cleveland Clinic

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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