NCT01433029

Brief Summary

The goal of this research study is to develop a method of rating videos of CAB procedures that will produce a reliable assessment of a cardiothoracic surgical trainee's technical proficiency. In addition, researchers also want to learn if using a video manual to train raters can help improve rater reliability.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Sep 2011

Longer than P75 for all trials

Geographic Reach
1 country

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2011

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

September 8, 2011

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 13, 2011

Completed
5.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 22, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 22, 2017

Completed
Last Updated

January 30, 2017

Status Verified

January 1, 2017

Enrollment Period

5.4 years

First QC Date

September 8, 2011

Last Update Submit

January 27, 2017

Conditions

Keywords

Surgical ProcedureAssessmentCardiothoracic SurgeryCoronary artery bypassCABVideo recordingsGlobal rating scaleGRSCardiothoracic surgeonSurgical trainees

Outcome Measures

Primary Outcomes (1)

  • Feasibility of Video Recordings of Cardiothoracic Surgery (CTS) Procedures

    Assessing 5 recorded procedures with qualified raters using two rating scales; a checklist developed using a consensus building project and a global rating scale (GRS) adapted from an established surgical assessment tool. The GRS uses a 5 point scale and behavioral anchors are provided for 1, 3, and 5 (a score of 1 equals a novice, 3 equals a competent surgeon, and 5 equals an expert). Raters have 1 month to view videos.

    1 month for rating

Study Arms (3)

Conventional Rater (CR)

CR Group receives conventional training from PI about how to rate coronary artery bypass (CAB) videos.

Other: Surgical Video Assessments

Video Rater (VR)

VR Group receives conventional training from PI about how to rate CAB videos, along with a video rater training manual.

Other: Surgical Video Assessments

CAB Recording

CAB recording of performance cardiothoracic surgeon or surgical trainee in 1st, 2nd, or 3rd year of training.

Other: Video Recording of CAB

Interventions

Rate performance of the surgeon/trainee in each CAB video performance (5 recorded procedures) using two rating scales, a checklist and the Global Rating Scale. Up to 38 different recorded procedures rated while on the study, each procedure lasting about 15 minutes.

Conventional Rater (CR)Video Rater (VR)

Each video begins when dissection of a coronary artery has begun and ends when all manipulation of anastomosis is complete. At least 6 separate anastomoses will be recorded, or at least 2-3 procedures. A ProXennon Surgical Headlight Camera System (a small camera that is mounted in place directly over a high-intensity light that is worn on the head) records the performance of the coronary artery bypass (CAB) procedures.

CAB Recording

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Cardiothoracic surgical trainee in their 1st, 2nd, or 3rd year of training. Experienced faculty are cardiothoracic surgeons who regularly perform coronary artery bypass (CAB) procedures and have at least 10 years of post-training experience.

You may qualify if:

  • The trainee must be a cardiothoracic surgical trainee in their 1st, 2nd, or 3rd year of training and must be currently enrolled at any of the following institutions: U.T. Health Science Center in Houston, The Texas Heart Institute/Baylor College of Medicine, U.T. San Antonio, U. T. Southwestern, U.T. M.D. Anderson Cancer Center, and The Methodist Hospital.
  • The trainee must provide an informed consent to participate.
  • The experience faculty must be a cardiothoracic surgeon who regularly performs CAB procedures and has at least 10 years of post-training experience.
  • The experienced faculty must provide written informed consent to participate.
  • The faculty rater must be a cardiothoracic surgeon who regularly performs CAB procedures, is practicing in an Adult Cardiothoracic Graduate Medical Evaluation (ACGME) approved CTS training program, and has practiced at least 5 years after certification by the American Board of Thoracic Surgery (ABTS). There is no restriction on geographic location.
  • The expert CAB surgeon for Consensus Building must be a cardiothoracic surgeon who regularly performs CAB procedures, is practicing in an ACGME approved CTS training program, and has practiced at least 10 years after certification by the ABTS. There is no restriction on geographic location.

You may not qualify if:

  • N/A

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

The University of Texas Southwestern Medical Center in Dallas

Dallas, Texas, 75390, United States

Location

Texas Heart Institute at St. Luke's Episcopal Hospital

Houston, Texas, 77030, United States

Location

The Methodist Hospital Research Institute

Houston, Texas, 77030, United States

Location

The University of Texas Medical School at Houston

Houston, Texas, 77030, United States

Location

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

The University of Texas Health Science Center at San Antonio

San Antonio, Texas, 78229, United States

Location

Related Links

Study Officials

  • Ara Vaporciyan, MD,BS

    M.D. Anderson Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 8, 2011

First Posted

September 13, 2011

Study Start

September 1, 2011

Primary Completion

January 22, 2017

Study Completion

January 22, 2017

Last Updated

January 30, 2017

Record last verified: 2017-01

Locations