Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
BEHAVIORAL - 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.


BEHAVIORAL: Epworth Richmond's Echocardiography Focused Year
a year long echo teaching program
Intervention code [1] 0 0
BEHAVIORAL
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
Trial website
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

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT02961439