Validation of Epworth Richmond's Echocardiography Education Focused Year (VEREEFY)

August 9, 2017 updated by: Kyle Brooks, Epworth Healthcare

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

Study Type

Observational

Enrollment (Actual)

252

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Victoria
      • Melbourne, Victoria, Australia, 3121
        • Epworth Richmond

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Registrar Participants and Patient Participant

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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.
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

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

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2016

Primary Completion (Actual)

May 1, 2017

Study Completion (Actual)

May 1, 2017

Study Registration Dates

First Submitted

November 3, 2016

First Submitted That Met QC Criteria

November 8, 2016

First Posted (Estimate)

November 11, 2016

Study Record Updates

Last Update Posted (Actual)

August 10, 2017

Last Update Submitted That Met QC Criteria

August 9, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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