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
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
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.
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.
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Exclusion Criteria:
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
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
Simulation-based teaching involves using done on a mannequin to simulate actual conditions
Also known as: Simulation
Standard teaching (problem based learning discussion) during cardiac/vascular rotation
Also known as: PBL
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
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..
| Milestone | Simulation-based Training | Problem Based Learning |
|---|---|---|
| Started | 24 | 24 |
| Completed | 13 | 15 |
| Not completed | 11 | 9 |
| Withdrew: Csf cases not present during rotation | 11 | 9 |
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").
| Participants | Simulation-based Training | Problem Based Learning |
|---|---|---|
| Score 14-16 | 10 | 11 |
| Score 11-13 | 2 | 4 |
| Score 10 and below | 1 | 0 |
Collected over Till patients' hospital discharge, an average of 3 days. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Simulation-based Training | 0/13 (0%) | 0/13 (0%) | 4/13 (30.8%) |
| Problem Based Learning | 0/15 (0%) | 0/15 (0%) | 3/15 (20%) |
| Event | Simulation-based Training | Problem Based Learning |
|---|---|---|
| Bloody tap during CSF catheter insertionInjury, poisoning and procedural complications | 2/13 | 1/15 |
| Bloody tinged CSF drainage in the postop periodInjury, poisoning and procedural complications | 1/13 | 2/15 |
| Spinal cord ischemia/new postoperative neurological deficitsInjury, poisoning and procedural complications | 1/13 | 0/15 |
| Postoperative CNS infection/meningitisInjury, poisoning and procedural complications | 0/13 | 0/15 |
| Age, Continuous(years) | Simulation-based Training | Problem Based Learning | Total |
|---|---|---|---|
| Mean | NA ± NA | NA ± NA | NA ± NA |
| Sex: Female, Male(Participants) | Simulation-based Training | Problem Based Learning | Total |
|---|---|---|---|
| Female | NA | NA | NA |
| Male | NA | NA | NA |
| Ethnicity (NIH/OMB)(Participants) | Simulation-based Training | Problem Based Learning | Total |
|---|---|---|---|
| Hispanic or Latino | NA | NA | NA |
| Not Hispanic or Latino | NA | NA | NA |
| Unknown or Not Reported | NA | NA | NA |
| Months of training as CA3(months) | Simulation-based Training | Problem Based Learning | Total |
|---|---|---|---|
| Mean | 6.8 ± 3.0 | 6.3 ± 3.4 | 6.5 ± 3.2 |
| Spinal Drain Placed in the past(Participants) | Simulation-based Training | Problem Based Learning | Total |
|---|---|---|---|
| Count of participants | 3 | 2 | 5 |
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