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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

Tracking Information
First Submitted Date  ICMJE July 15, 2016
First Posted Date  ICMJE July 25, 2016
Last Update Posted Date October 20, 2017
Actual Study Start Date  ICMJE April 2016
Actual Primary Completion Date May 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 20, 2016)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 20, 2016)
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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Evaluation of Simulator Training on TEE Performance in Residents
Official Title  ICMJE Evaluation of Simulator Training on Transesophageal Echocardiography (TEE) Performance in Anaesthesia Residents
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.

Detailed Description

The clinical utility of transesophageal echocardiography is increasingly recognized in perioperative medicine. However, 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. According tot he ASE and SCA the principal goal of the basic TEE examination is intraoperative monitoring. The basic TEE examination focus on the 11 most relevant views, which can enable anesthesiologists to diagnose general hemodynamic instability and its etiology in surgical patients and can in further consequence influence surgical outcome. The 11 basic TEE views are easier to remember and faster to obtain than a detailed 20 view standard examination.

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.

Residents will be recruited by invitation for TEE training during their first or second year of residency in a large teaching hospital (AKH Wien).

The study will be conducted during 3 consecutive study days with a final exam (theoretical and practical on the third day).

The first study day will start with a lecture about the tested subjects, especially physical principles and heart anatomy. Then the students will complete a theoretical test (TT1) about basic knowledge for TEE, such as principles of ultrasonography, heart anatomy, indications as well as contraindications, patient safety and complications, probe manipulation and knowledge about basic pathologies (Severe hypovolemia, LV failure, RV failure, Tamponade, acute massive left-sided valvular regurgitation, circulatory arrest during resuscitation and after successful resuscitation.

Afterwards the participants will be randomised. After that, all students will get introduced to a protocol, which explains the examination process.

Group A will be introduced to the virtual TEE online (http://pie.med.utoronto.ca/TEE/), group B to the simulator (CAE Vimedix Simulator) and group C to the TEE training in the operation room.

From now on each student in group B and C will receive 2 practical sessions á 40 minutes within the next 2 weeks. Group A will study two times with the virtual TEE. The first practical session can be done on the first study day, the following one within 2 weeks and the final study day with the theoretical and practical test (TT2 and PT3) should be within 1 week after the second training session. All teaching sessions will start with a practical test (PT1 and PT2). This test will contain the 11 basic TEE views.

After the 2 teaching sessions all students will attend a second theoretical test (TT2) and a final practical tests (PT3). For the practical test the students should adjust and name the 11 basic TEE views within 10 minutes.

There will ba a follow up after 3 months with both a theoretical and a practical test (TT3 and PT4).

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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Condition  ICMJE Satisfaction
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • A virtual teaching
    Group A will be introduced to the virtual TEE online (http://pie.med.utoronto.ca/TEE/)
    Interventions:
    • Other: theoretical test
    • Other: practical test
  • B simulator
    Group B will be introduced to the simulator (CAE Vimedix Simulator)
    Interventions:
    • Other: theoretical test
    • Other: practical test
  • C hands on OR
    group C will be introduced to the TEE training in the operation room.
    Interventions:
    • Other: theoretical test
    • Other: practical test
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 20, 2016)
54
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE September 2017
Actual Primary Completion Date May 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

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

Exclusion Criteria:

  • prior knowledge of echocardiography
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Austria
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02842632
Other Study ID Numbers  ICMJE 1057/2016
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Ulrike Weber, Medical University of Vienna
Study Sponsor  ICMJE Ulrike Weber
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Ulrike Weber, MD, PhD Medical University of Vienna
PRS Account Medical University of Vienna
Verification Date October 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP