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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT02961439




Registration number
NCT02961439
Ethics application status
Date submitted
3/11/2016
Date registered
11/11/2016
Date last updated
10/08/2017

Titles & IDs
Public title
Validation of Epworth Richmond's Echocardiography Education Focused Year
Scientific title
Validation of Epworth Richmond's Echocardiography Education Focused Year
Secondary ID [1] 0 0
EH2016-133
Universal Trial Number (UTN)
Trial acronym
VEREEFY
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Shock, Cardiogenic 0 0
Cardiac Tamponade 0 0
Pulmonary Embolism 0 0
Hypovolemia 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system
Blood 0 0 0 0
Clotting disorders
Respiratory 0 0 0 0
Other respiratory disorders / diseases
Cardiovascular 0 0 0 0
Other cardiovascular diseases
Blood 0 0 0 0
Other blood disorders

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Behaviour - Epworth Richmond's Echocardiography Focused Year

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.


Behaviour: Epworth Richmond's Echocardiography Focused Year
a year long echo teaching program
Intervention code [1] 0 0
Behaviour
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Agreement between registrar and expert assessment of Left ventricular (LV) function
Timepoint [1] 0 0
Four months
Secondary outcome [1] 0 0
Comparison of expert and registrar quantitative measures of Left vwentricular Internal Diameter in Diastole (LVIDd)
Timepoint [1] 0 0
Four months
Secondary outcome [2] 0 0
Comparison of expert and registrar quantitative measures of Left Ventricular Outflow Tract (LVOT) diameter
Timepoint [2] 0 0
Four months
Secondary outcome [3] 0 0
Comparison of expert and registrar quantitative measures of Left Ventricular Outflow Tract Velocity Time Integral (LVOT VTI)
Timepoint [3] 0 0
Four months
Secondary outcome [4] 0 0
Comparison of expert and registrar quantitative measures of TR V max
Timepoint [4] 0 0
Four months
Secondary outcome [5] 0 0
Comparison of expert and registrar quantitative measures of Tricuspid annular Plane Systolic Excursion (TAPSE)
Timepoint [5] 0 0
Four months
Secondary outcome [6] 0 0
Comparison of expert and registrar quantitative measures of IVC diameter
Timepoint [6] 0 0
Four months
Secondary outcome [7] 0 0
Comparison of expert and registrar qualitative assessment of pericardial fluid
Timepoint [7] 0 0
Four months
Secondary outcome [8] 0 0
Comparison of expert and registrar qualitative assessment of Left Ventricle : Right Ventricle size ratio
Timepoint [8] 0 0
Four months

Eligibility
Key inclusion criteria
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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
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 design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/11/2016
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/05/2017
Sample size
Target
Accrual to date
Final
252
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Epworth Richmond - Melbourne
Recruitment postcode(s) [1] 0 0
3121 - Melbourne

Funding & Sponsors
Primary sponsor type
Other
Name
Epworth Healthcare
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
University of Melbourne
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT02961439
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT02961439