Virtual Temporal Bone Surgery: Defining and Translating Metrics

This study is not yet open for participant recruitment.
Verified December 2011 by Nationwide Children's Hospital
Sponsor:
Collaborators:
Ohio State University
Information provided by (Responsible Party):
Gregory Wiet, Nationwide Children's Hospital
ClinicalTrials.gov Identifier:
NCT01493765
First received: December 13, 2011
Last updated: December 16, 2011
Last verified: December 2011
  Purpose

The goal of this project is to improve the efficiency of training and assessment of technical skill in surgical treatment of otologic disease. Through previous funding, we have developed an intuitive virtual simulation environment to be used as an adjuvant for teaching temporal bone surgery. Using direct-volume visualization techniques with integrated stereoscopic display, haptic (force) feedback, and aural simulation, we have achieved a straightforward, low-cost learning environment ready for translation into a practical training and assessment tool. This application challenges and seeks to shift current practice in clinical training by translating the simulation environment into a vehicle for curriculum development, technical skills assessment, and dissemination. The intent is to provide more accessible, inexpensive, safe, and deliberate practice with objective and continuous quantitative, objective assessment in the early stages of training.


Condition Intervention Phase
Focus: Otologic Surgery Training
Other: Simulator training with expert scoring
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Investigator)
Official Title: Virtual Temporal Bone Surgery: Defining and Translating Metrics

Resource links provided by NLM:


Further study details as provided by Nationwide Children's Hospital:

Primary Outcome Measures:
  • Performance on a set of validated metrics for temporal bone surgery. [ Time Frame: one year ] [ Designated as safety issue: No ]
    A collection of metrics designed to measure technical performance during a mastoidectomy will be validated by expert survey. These metrics will be translated to an automated system within the surgical simulation system. Resident subjects will be asked to perform the surgical procedure (mastoidectomy) within the simulation. Experts will then rate the playback of the performances using the validated metrics. These results will be compared to the automated scoring system. A conclusion will be drawn about the accuracy of the automated process compared to the expert rated process.


Estimated Enrollment: 170
Study Start Date: July 2013
Estimated Study Completion Date: July 2015
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Intervention Details:
    Other: Simulator training with expert scoring
    Residents will be trained using surgical simulation
Detailed Description:

The aims of this research include: 1) definition of standardized metrics for otological surgical techniques, 2) the translation of those standards into objective criteria for use in a computer synthesized surgical environment, and 3) the correlation between expert evaluation and computer automated assessment of resident proficiency.

The interactions will be computer-based and include:

Experts will learn to use the system so that they can evaluate the quality of translation of metrics to the simulation environment.

Evaluations will be in the form of anonymous web-based surveys. Experts serve as a focus group.

Residents will use the simulation environment to perform surgical procedures on virtual specimens. Residents will then evaluate the quality of the simulation environment via anonymous web-based surveys.

Experts will use the simulation environment to evaluate and rate the residents performance.

The computer environment will be used to automatically assess and rate the residents performance.

Expert and computer assessment will be compared.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Specific knowledge of otologic surgery.

Exclusion Criteria:

  • request not to participate
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01493765

Contacts
Contact: Gregory J Wiet, MD 614-722-6600 gregory.wiet@nationwidechildrens.org

Locations
United States, Ohio
The Ohio State University Not yet recruiting
Columbus, Ohio, United States, 43210
Contact: wiet    614-722-6600      
Sponsors and Collaborators
Nationwide Children's Hospital
Ohio State University
  More Information

Additional Information:
No publications provided

Responsible Party: Gregory Wiet, Associate Professor of Otolaryngology and Biomedical Informatics, Nationwide Children's Hospital
ClinicalTrials.gov Identifier: NCT01493765     History of Changes
Other Study ID Numbers: R01 DC011321-01 A1
Study First Received: December 13, 2011
Last Updated: December 16, 2011
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on April 17, 2014