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Imaging of Heart DiseaseISITOENCT02537639

Impact of Simulator-based Training in Transoesophageal Echocardiography

An observational study of Imaging of Heart Disease, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 25 to 65 years
Conditions the study is for
Imaging of Heart Disease
What is being tested?
Transesophageal echocardiography simulator
Type of treatment
Medical device
How many people
45 participants
Where
1 siteSwitzerland
Study dates
May 2016to Jul 2016
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 25 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Trainees in critical care

Who may be able to join

  • No prior hands-on training in echocardiography
  • Trainee in critical care
  • Written informed consent

Who cannot join

  • Prior hands-on training in echocardiography

Trial locations and contacts

1 site in 1 country.

Switzerland1 site
  • Department for Critical Care

    Bern, 3010

Other trials in Switzerland

About this study

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.

Read the detailed 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.

Being tested
Transesophageal echocardiography simulator
Keywords
Simulator in transesophageal echocardiography

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Transesophageal echocardiography simulatorDevice

Study groups in NCT02537639
Study groupRoleWhat they receive
Control groupControl group. Standard teaching in transesophageal echocardiography.
Intervention groupIntervention group. Additional teaching with a transesophageal echocardiography simulator.
Receives: Device: Transesophageal echocardiography simulator

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Quality of acquired images

    Assessed by two cardiologists based on predefined quality criteria

    Measured: After training completion, expected to be on average between 1 and no more than 5 days

Secondary outcomes (1)
  1. Time needed to perform the examination

    Measured: After training completion, expected to be on average between 1 and no more than 5 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Sep 2015 (estimated)
  2. Study startMay 2016
  3. Primary completionJun 2016
  4. Study completionJul 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
45 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02537639
Sponsor's protocol ID
Andreas Bloch
Acronym
ISITOE
Status last verified
Oct 2016
First submitted
29 Jul 2015
Last updated
1 Nov 2016
Results posted
No
Data monitoring committee
No

Publications

  • Bloch A, von Arx R, Etter R, Berger D, Kaiser H, Lenz A, Merz TM. Impact of Simulator-Based Training in Focused Transesophageal Echocardiography: A Randomized Controlled Trial. Anesth Analg. 2017 Oct;125(4):1140-1148. doi: 10.1213/ANE.0000000000002351.

    PubMed 28817424

Questions about this trial

What is this clinical trial studying?

An observational study of Imaging of Heart Disease, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Quality of acquired images (time frame: After training completion, expected to be on average between 1 and no more than 5 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02537639, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Nov 2016.

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