Evaluation of a Simulation Based Workshop in an Anesthesia Residency Program

NCT03545984 | Completed Results

• 1 other identifier: 14-613
• Study Type: interventional
• Target: 48
• Locations: 0 countries
• Sites: N/A

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

Conditions

Cerebrospinal Fluid Drainage Catheter

Outcome Measures

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").

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

Study Arms (2)

simulation-based training

EXPERIMENTAL

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

problem based learning

ACTIVE COMPARATOR

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

Simulation-based learning OTHER

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

Also known as: Simulation

simulation-based training

interactive problem based learning OTHER

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

Also known as: PBL

problem based learning

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• The Cleveland Clinic: lead

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.

Results Point of Contact

• Title: Dr. Maged Argalious
• Organization: Cleveland Clinic

ARGALIM@ccf.org

+12164452064

Study Officials

• Maged Argalious, MD

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The staff anesthesiologist evaluating a resident on spinal drain placement would NOT be aware of the resident's group allocation.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Prospective randomized educational trial

Study Record Dates

• First Submitted: May 2, 2018
• First Posted: June 6, 2018
• Study Start: June 5, 2014
• Primary Completion: June 5, 2017
• Study Completion: July 25, 2018
• Last Updated: August 6, 2019
• Results First Posted: August 6, 2019

Record last verified: 2019-06

Data Sharing

• IPD Sharing: Will not share