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.
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.
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.
- Conditions
- Imaging of Heart Disease
- 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 group | Role | What they receive |
|---|---|---|
| Control group | Control group. Standard teaching in transesophageal echocardiography. | |
| Intervention group | Intervention 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.
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)
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.
- First posted1 Sep 2015 (estimated)
- Study startMay 2016
- Primary completionJun 2016
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Imaging of Heart DiseaseStudies of the same condition, open and under way.
- More trials run by Insel Gruppe AG, University Hospital BernThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Andreas Bloch, Principal investigator, Department for critical care, university hospital bern
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
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Simulator-based Training in Transoesophageal Echocardiography
- ClinicalTrials.gov ID
- NCT02537639
- Acronym / sponsor ID
- ISITOE / Andreas Bloch
- Conditions
- Imaging of Heart Disease
- Keywords
- Simulator in transesophageal echocardiography
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- Study start
- May 2016
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 1 Sep 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | – | –Control group. Standard teaching in transesophageal echocardiography. |
| Intervention group | – | Device: Transesophageal echocardiography simulatorIntervention group. Additional teaching with a transesophageal echocardiography simulator. |
Who may qualify
- Ages
- 25 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Trainees in critical care
Key inclusion criteria (3 listed)
- No prior hands-on training in echocardiography
- Trainee in critical care
- Written informed consent
Key exclusion criteria (1 listed)
- Prior hands-on training in echocardiography
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transesophageal echocardiography simulator | Device | Intervention group |
Primary outcome
Quality of acquired images
Time frame: After training completion, expected to be on average between 1 and no more than 5 days
Assessed by two cardiologists based on predefined quality criteria
1 secondary outcome
Time needed to perform the examination
Time frame: After training completion, expected to be on average between 1 and no more than 5 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2016.
- Derived from this study: PubMed 28817424Bloch 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andreas Bloch principal investigator
Department for critical care, university hospital bern
1 site in 1 country: see every site and its status.
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.