- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02961439
Validation of Epworth Richmond's Echocardiography Education Focused Year (VEREEFY)
The use of echocardiography in intensive care is a developing field. In expert hands echocardiography has proven its utility in diagnosing cardiac pathology, differentiating shock states and in haemodynamic monitoring. However, whether the results obtained by experts can be generalized to trainees or specialists with limited training remains unclear. Further, concerns around training time and cost for intensive care staff have been a factor in limiting the uptake of echocardiography in intensive care.
The investigators aim to assess the diagnostic accuracy of Australian ICU doctors in training after completion of the current minimum training. After completing a structured teaching program and 30 mentored training scans trainees will be assessed on their accuracy with echocardiography. In the research phase trainees will complete a further 40 scans with each one matched with an expect scan. The results from the expert and trainee scans will be compared to determine the trainee's accuracy.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Victoria
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Melbourne, Victoria, Australia, 3121
- Epworth Richmond
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Registrar Inclusion:
- At least 12 month appointment in Epworth Richmond ICU
- Completion of theoretical component of Epworth Richmond ICU echocardiography program
- Completion of 30 echocardiography scans
Registrar Exclusion:
• Previous experience in echocardiography prior to commencing at Epworth Richmond.
Patient Inclusion
- Patient in ICU or CCU
- 18 years or older
- Not likely to be discharged before completion of the scan
Patient Exclusion
- Likely to be discharged within next two hours
- Atrial fibrillation
- Presence of subcostal or intercostal drains or pneumothorax
- Unable to be consented
- Treating intensivist deems inclusion in study not suitable.
Study Plan
How is the study designed?
Design Details
- Observational Models: Other
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Patient Participants
Patient participants are adult patients in the Epworth Richmond Intensive care Unit.
They are not the focus of the research but rather represent a general population of ICU patients that require echocardiography in the management of their critical illness.
They will be a mix of medical and surgical patients some of whom are receiving mechanical ventilation, have movement restrictions, high BMI or other impediments to performing echocardiography.
|
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Registrar Participants
Registrar participants are doctors in training in ICU.
They have completed a formal echo teaching program and completed a logbook of 30 supervised scans.
They are the focus of the research and are being assessed on their diagnostic accuracy with echocardiography.
|
a year long echo teaching program
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Agreement between registrar and expert assessment of Left ventricular (LV) function
Time Frame: Four months
|
Four months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Comparison of expert and registrar quantitative measures of Left vwentricular Internal Diameter in Diastole (LVIDd)
Time Frame: Four months
|
Four months
|
Comparison of expert and registrar quantitative measures of Left Ventricular Outflow Tract (LVOT) diameter
Time Frame: Four months
|
Four months
|
Comparison of expert and registrar quantitative measures of Left Ventricular Outflow Tract Velocity Time Integral (LVOT VTI)
Time Frame: Four months
|
Four months
|
Comparison of expert and registrar quantitative measures of TR V max
Time Frame: Four months
|
Four months
|
Comparison of expert and registrar quantitative measures of Tricuspid annular Plane Systolic Excursion (TAPSE)
Time Frame: Four months
|
Four months
|
Comparison of expert and registrar quantitative measures of IVC diameter
Time Frame: Four months
|
Four months
|
Comparison of expert and registrar qualitative assessment of pericardial fluid
Time Frame: Four months
|
Four months
|
Comparison of expert and registrar qualitative assessment of Left Ventricle : Right Ventricle size ratio
Time Frame: Four months
|
Four months
|
Collaborators and Investigators
Sponsor
Collaborators
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- EH2016-133
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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