Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT02537639 |
Other study ID # |
Andreas Bloch |
Secondary ID |
|
Status |
Completed |
Phase |
N/A
|
First received |
July 29, 2015 |
Last updated |
October 31, 2016 |
Start date |
May 2016 |
Est. completion date |
July 2016 |
Study information
Verified date |
October 2016 |
Source |
University Hospital Inselspital, Berne |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
Switzerland: Ethikkommission |
Study type |
Observational
|
Clinical Trial Summary
The investigators would like to evaluate how well intensive care trainees without previous
experience in transesophageal echocardiography are able to perform a transesophageal
echocardiography study in the clinical setting after completing a simulator based training
compared to conventional training.
Description:
Background
Echocardiography is currently the sole imaging modality at the bedside that provides
real-time information on cardiac anatomy and function. Echocardiography is increasingly used
in the intensive care unit (ICU) setting for the focussed hemodynamic assessment of patients
with cardiorespiratory compromise. The principal role for focussed echocardiography is the
time-sensitive assessment of the symptomatic patient. This evaluation primarily includes the
assessment for pericardial effusion, the evaluation of relative chamber size, global cardiac
and valvular function and patient volume status. The clinical impact of echocardiography for
the treatment of critically ill patients with hemodynamic compromise is well documented and
increasing general consensus exists, that all physicians in charge of critically ill
patients should be trained in focussed echocardiography. Accordingly there is an urgent need
for specific training in echocardiography.
Transoesophageal echocardiography (TOE) is besides transthoracic echocardiography (TTE) the
main imaging modality in the ICU setting. TTE image quality is often compromised by lung
inflation in ventilated patients or by the presence of dressings or drains in locations used
for image acquisition. It thus seems reasonable to suggest that every critical care
physician should be able to perform a focused TOE. However, a multitude of barriers continue
to limit TOE training including time constraints in busy ICUs, limited number of appropriate
cases and a lack of experienced teaching faculty. Proficiency in TOE image acquisition
requires in-depth knowledge of three-dimensional cardiac anatomy and repetitive supervised
hands-on experience to develop the necessary manual skills. Typically TOE skill acquisition
occurs in real time in the ICU while caring for a patient, thus the time that can be devoted
to training is limited. However, using a semi-invasive imaging modality in ICU patients for
training solely for training purposes is problematic due to the associated (minimal) risks
and patient discomfort. Recently commercially available TOE simulation systems have been
introduced. These systems allow for patient-independent training of TOE skills using
simulations of the human heart. When used as an educational adjunct standardized TOE
simulation training in a virtual reality environment may lead to a more rapid development of
psychomotor skills. TOE simulators also offer the possibility to simulate pathological
conditions of the heart and thus may facilitate training in image interpretation.
The purpose of this study is to determine the effectiveness of a simulator based TOE
training curriculum to train all necessary components of focused critical care
echocardiography in accordance with the basic perioperative transesophageal examination as
defined by the American Society of Echocardiography and the Society of Cardiovascular
Anesthesiologists. This includes the psychomotor skills necessary for obtaining
echocardiographic images of sufficient quality according to established quality scoring
systems and the ability of recognizing the relevant anatomic structures as well as image
interpretation when evaluating a hemodynamically compromised patient.
Objective
To evaluate the effect of a simulator in the training for transesophageal echocardiography
Methods
The investigators will perform a prospective, observational trial investigating the impact
of simulator TOE training in novice operators on quality of imaging, correct image
interpretation and resource use when performing a focussed TOE examination in ICU patients.
Forty-fife ICU trainees without previous hands-on echocardiography skills will undergo a
formal training consisting of 4 hours of theoretical instructions including basics of
transesophageal echocardiography, cardiac anatomy, standard views as well as physiology and
pathophysiology. Instructions will be provided by expert TOE operators. 30 of these trainees
will additionally be trained using the HeartWorks TOE simulator. This training consists of 4
sessions of supervised practice using the TOE simulator.
After conclusion of the training program the trainees will perform one basic perioperative
echocardiography study using the HeartWorks TOE simulator and two basic perioperative
echocardiography studies in real ICU patients.