Shock, CardiogenicVEREEFYNCT02961439
Validation of Epworth Richmond's Echocardiography Education Focused Year
An observational study of Shock, Cardiogenic and Cardiac Tamponade, run by Epworth Healthcare at 1 site in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Shock, Cardiogenic, Cardiac Tamponade, Pulmonary Embolism
- What is being tested?
- Epworth Richmond's Echocardiography Focused Year
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 252 participants
- Where
- 1 siteAustralia
- Study dates
- Nov 2016to 1 May 2017
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Registrar Participants and Patient Participant
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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Shock, Cardiogenic, Cardiac Tamponade, Pulmonary Embolism, Hypovolemia
- Being tested
- Epworth Richmond's Echocardiography Focused Year
- Medical subject headings
- Shock, Cardiogenic, Cardiac Tamponade, Pulmonary Embolism, Hypovolemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Epworth Richmond's Echocardiography Focused YearBehavioural
a year long echo teaching program
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Epworth Richmond's Echocardiography Focused Year |
What is being measured
The primary outcome is the main question the study is designed to answer.
Agreement between registrar and expert assessment of Left ventricular (LV) function
Measured: Four months
Secondary outcomes (8)
Comparison of expert and registrar quantitative measures of Left vwentricular Internal Diameter in Diastole (LVIDd)
Measured: Four months
Comparison of expert and registrar quantitative measures of Left Ventricular Outflow Tract (LVOT) diameter
Measured: Four months
Comparison of expert and registrar quantitative measures of Left Ventricular Outflow Tract Velocity Time Integral (LVOT VTI)
Measured: Four months
Comparison of expert and registrar quantitative measures of TR V max
Measured: Four months
Comparison of expert and registrar quantitative measures of Tricuspid annular Plane Systolic Excursion (TAPSE)
Measured: Four months
Comparison of expert and registrar quantitative measures of IVC diameter
Measured: Four months
Comparison of expert and registrar qualitative assessment of pericardial fluid
Measured: Four months
Comparison of expert and registrar qualitative assessment of Left Ventricle : Right Ventricle size ratio
Measured: Four months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2016 (estimated)
- Study startNov 2016
- Primary completion1 May 2017
- Study completion1 May 2017
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 Shock, CardiogenicStudies of the same condition, open and under way.
- 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
- Other
- Time perspective
- Prospective
- Enrolment
- 252 participants (actual)
Sponsor and investigators
- Lead sponsor
- Epworth Healthcare
- Sponsor type
- University, hospital or other
- Collaborators
- University of Melbourne
- Responsible party
- Principal investigator, Kyle Brooks, Epworth Healthcare
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02961439
- Sponsor's protocol ID
- EH2016-133
- Acronym
- VEREEFY
- Status last verified
- Aug 2017
- First submitted
- 3 Nov 2016
- Last updated
- 10 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Brooks KS, Tan LH, Rozen TH, Kelly D, McKenzie DP, Calafiore P, Barrett J. Validation of Epworth Richmond's Echocardiography Education Focused Year. Crit Care Med. 2020 Jan;48(1):e34-e39. doi: 10.1097/CCM.0000000000004076.
PubMed 31725442
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of Epworth Richmond's Echocardiography Education Focused Year
- ClinicalTrials.gov ID
- NCT02961439
- Acronym / sponsor ID
- VEREEFY / EH2016-133
- Conditions
- Shock, Cardiogenic, Cardiac Tamponade, Pulmonary Embolism, Hypovolemia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 252 participants (actual)
- Lead sponsor
- Epworth HealthcareUniversity, hospital or other
- Collaborators
- University of Melbourne
- Study start
- Nov 2016
- Primary completion
- 1 May 2017 (actual)
- Study completion
- 1 May 2017 (actual)
- First posted
- 11 Nov 2016 (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 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 design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | – | Behavioral: Epworth Richmond's Echocardiography Focused YearRegistrar 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Registrar Participants and Patient Participant
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 |
|---|---|---|
| Epworth Richmond's Echocardiography Focused Yeara year long echo teaching program | Behavioural | Registrar Participants |
Primary outcome
Agreement between registrar and expert assessment of Left ventricular (LV) function
Time frame: Four months
8 secondary outcomes
Comparison of expert and registrar quantitative measures of Left vwentricular Internal Diameter in Diastole (LVIDd)
Time frame: Four months
Comparison of expert and registrar quantitative measures of Left Ventricular Outflow Tract (LVOT) diameter
Time frame: Four months
Comparison of expert and registrar quantitative measures of Left Ventricular Outflow Tract Velocity Time Integral (LVOT VTI)
Time frame: Four months
Comparison of expert and registrar quantitative measures of TR V max
Time frame: Four months
Comparison of expert and registrar quantitative measures of Tricuspid annular Plane Systolic Excursion (TAPSE)
Time frame: Four months
Comparison of expert and registrar quantitative measures of IVC diameter
Time frame: Four months
Comparison of expert and registrar qualitative assessment of pericardial fluid
Time frame: Four months
Comparison of expert and registrar qualitative assessment of Left Ventricle : Right Ventricle size ratio
Time frame: Four months
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 10 Aug 2017.
- Derived from this study: PubMed 31725442Brooks KS, Tan LH, Rozen TH, Kelly D, McKenzie DP, Calafiore P, Barrett J. Validation of Epworth Richmond's Echocardiography Education Focused Year. Crit Care Med. 2020 Jan;48(1):e34-e39. doi: 10.1097/CCM.0000000000004076.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Shock, Cardiogenic and Cardiac Tamponade, run by Epworth Healthcare at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 10 Aug 2017. 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 Australia. 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?
Agreement between registrar and expert assessment of Left ventricular (LV) function (time frame: Four months). 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 NCT02961439, 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 10 Aug 2017.