Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Evaluation of Simulator Training on TEE Performance in Residents (TEESimulation)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02842632
Recruitment Status : Completed
First Posted : July 25, 2016
Last Update Posted : October 20, 2017
Sponsor:
Information provided by (Responsible Party):
Ulrike Weber, Medical University of Vienna

Brief Summary:

Training in TEE is based on hands-on training in the operation room which is time consuming and therefore its use and experience is limited among anesthesiologists.

Recent studies demonstrate that simulation-based education is also superior to a conventional didactic system and superior to hands-on teaching in the OR in terms of theoretical knowledge in echocardiography. So far there is no study evaluating the study effect in obtaining the 11 basic TEE views as recommended by the American Society of Echocardiography (ASE) and the Society of Cardiovascular Anesthesiologists (SCA) between simulator training and training in the operation room in residents with no prior knowledge of echocardiography. The basic TEE examination focus on the 11 most relevant views.

Therefore the investigators want to assess if there is a difference in the study effect in obtaining the 11 basic TEE views and also in theoretical knowledge in 3 groups of residents with no prior knowledge of echocardiography:

the simulation group (CAE Vimedix Simulator), the hands-on OR group and the online group (http://pie.med.utoronto.ca/TEE/).

prospective randomized single-center study. The investigators want to include 51 anaesthesia residents (17 per group) in their first or second year of training with no prior knowledge of echocardiography in this randomized, Controlled single-centre study.

The investigators want to assess the pre- and post training scores of the theoretical multiple choice test and the practical test in all 3 groups. The multiple choice test consists of 50 questions with 1 point per question (max. 50 points) and the practical test is an evaluation of 11 basic perioperative TEE examination on the simulator (CAE Vimedix Simulator). Each view is evaluated on a scale of 0 to 10 according to predetermined criteria including image angle, overall clarity and visualization of 3 major anatomic structures pertinent to each view. Each view can receive a maximum score of 10 and each study a maximum of 109 (ME asc. aortic LAX has only 2 main structures). Further the time to adjust each view and the time to complete the basic TEE Examination will be assessed.


Condition or disease Intervention/treatment Phase
Satisfaction Other: theoretical test Other: practical test Not Applicable

Show Show detailed description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 54 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Evaluation of Simulator Training on Transesophageal Echocardiography (TEE) Performance in Anaesthesia Residents
Actual Study Start Date : April 2016
Actual Primary Completion Date : May 2017
Actual Study Completion Date : September 2017

Arm Intervention/treatment
A virtual teaching
Group A will be introduced to the virtual TEE online (http://pie.med.utoronto.ca/TEE/)
Other: theoretical test
The theoretical test is a multiple choice test which consists of 50 questions with 1 point per question (max. 50 points). It will be done before the teaching, after the 2 teaching sessions and 3 Months after the study

Other: practical test
The practical test is an evaluation of 11 basic perioperative TEE examination on the simulator (CAE Vimedix Simulator). Each view is evaluated on a scale of 0 to 10 according to predetermined criteria including image angle, overall clarity and visualization of 3 major anatomic structures pertinent to each view. Each view can receive a maximum score of 10 and each study a maximum of 109 (ME asc. aortic LAX has only 2 main structures). It will be done after the first and second teaching session, and 3 Months after the study.

B simulator
Group B will be introduced to the simulator (CAE Vimedix Simulator)
Other: theoretical test
The theoretical test is a multiple choice test which consists of 50 questions with 1 point per question (max. 50 points). It will be done before the teaching, after the 2 teaching sessions and 3 Months after the study

Other: practical test
The practical test is an evaluation of 11 basic perioperative TEE examination on the simulator (CAE Vimedix Simulator). Each view is evaluated on a scale of 0 to 10 according to predetermined criteria including image angle, overall clarity and visualization of 3 major anatomic structures pertinent to each view. Each view can receive a maximum score of 10 and each study a maximum of 109 (ME asc. aortic LAX has only 2 main structures). It will be done after the first and second teaching session, and 3 Months after the study.

C hands on OR
group C will be introduced to the TEE training in the operation room.
Other: theoretical test
The theoretical test is a multiple choice test which consists of 50 questions with 1 point per question (max. 50 points). It will be done before the teaching, after the 2 teaching sessions and 3 Months after the study

Other: practical test
The practical test is an evaluation of 11 basic perioperative TEE examination on the simulator (CAE Vimedix Simulator). Each view is evaluated on a scale of 0 to 10 according to predetermined criteria including image angle, overall clarity and visualization of 3 major anatomic structures pertinent to each view. Each view can receive a maximum score of 10 and each study a maximum of 109 (ME asc. aortic LAX has only 2 main structures). It will be done after the first and second teaching session, and 3 Months after the study.




Primary Outcome Measures :
  1. Change in Score from the theoretical test [ Time Frame: change from baseline to 1 day after training ]
    Change from Baseline test score at 1 day after training


Secondary Outcome Measures :
  1. Change in score from practical test [ Time Frame: change from baseline to 1 day after training ]
    Change from Baseline test score at 1 day after training



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • anaesthesia residents in their first or second year of clinical training

Exclusion Criteria:

  • prior knowledge of echocardiography

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02842632


Locations
Layout table for location information
Austria
Medical university of vienna, General hospital of Vienna
Vienna, Austria, 1090
Sponsors and Collaborators
Ulrike Weber
Investigators
Layout table for investigator information
Principal Investigator: Ulrike Weber, MD, PhD Medical University of Vienna
Layout table for additonal information
Responsible Party: Ulrike Weber, Dr. Ulrike Weber, Medical University of Vienna
ClinicalTrials.gov Identifier: NCT02842632    
Other Study ID Numbers: 1057/2016
First Posted: July 25, 2016    Key Record Dates
Last Update Posted: October 20, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No