NCT02842632

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
54

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2016

Geographic Reach
1 country

1 active site

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

April 1, 2016

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

July 15, 2016

Completed
10 days until next milestone

First Posted

Study publicly available on registry

July 25, 2016

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2017

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2017

Completed
Last Updated

October 20, 2017

Status Verified

October 1, 2017

Enrollment Period

1.1 years

First QC Date

July 15, 2016

Last Update Submit

October 19, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

  • Change in Score from the theoretical test

    Change from Baseline test score at 1 day after training

    change from baseline to 1 day after training

Secondary Outcomes (1)

  • Change in score from practical test

    change from baseline to 1 day after training

Study Arms (3)

A virtual teaching

OTHER

Group A will be introduced to the virtual TEE online (http://pie.med.utoronto.ca/TEE/)

Other: theoretical testOther: practical test

B simulator

OTHER

Group B will be introduced to the simulator (CAE Vimedix Simulator)

Other: theoretical testOther: practical test

C hands on OR

OTHER

group C will be introduced to the TEE training in the operation room.

Other: theoretical testOther: practical test

Interventions

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

A virtual teachingB simulatorC hands on OR

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.

A virtual teachingB simulatorC hands on OR

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • prior knowledge of echocardiography

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical university of vienna, General hospital of Vienna

Vienna, 1090, Austria

Location

MeSH Terms

Conditions

Personal Satisfaction

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Ulrike Weber, MD, PhD

    Medical University of Vienna

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Dr. Ulrike Weber

Study Record Dates

First Submitted

July 15, 2016

First Posted

July 25, 2016

Study Start

April 1, 2016

Primary Completion

May 1, 2017

Study Completion

September 1, 2017

Last Updated

October 20, 2017

Record last verified: 2017-10

Data Sharing

IPD Sharing
Will not share

Locations