Ignite Creation Date:
2025-12-24 @ 10:00 PM
Ignite Modification Date:
2026-01-01 @ 7:47 PM
Study NCT ID:
NCT02842632
Status:
COMPLETED
Last Update Posted:
2017-10-20
First Post:
2016-07-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Simulator Training on TEE Performance in Residents
Sponsor:
Ulrike Weber
Organization:
Study Overview
Official Title:
Evaluation of Simulator Training on Transesophageal Echocardiography (TEE) Performance in Anaesthesia Residents
Status:
COMPLETED
Status Verified Date:
2017-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TEESimulation
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.
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 รก 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.
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 รก 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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: