Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000717853
Ethics application status
Approved
Date submitted
14/04/2021
Date registered
9/06/2021
Date last updated
9/06/2021
Date data sharing statement initially provided
9/06/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
Emergency Department (ED) Bedside UltraSound & Satisfaction Trial (BUSS Trial): A Randomised Controlled Trial of Bedside Echocardiogram in patients with ‘low risk’ chest pain in the ED.
Scientific title
Emergency Department (ED) Bedside UltraSound & Satisfaction Trial (BUSS Trial): A Randomised Controlled Trial of Bedside Echocardiogram in adult patients with ‘low risk’ chest pain in the ED.
Secondary ID [1] 303901 0
Nil known
Universal Trial Number (UTN)
Trial acronym
BUSS Trial
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chest pain 321504 0
Patient satisfaction 321505 0
Condition category
Condition code
Emergency medicine 319253 319253 0 0
Other emergency care

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The primary outcome measure is a patient satisfaction survey regarding their treatment/stay in ED.

Patients with low-risk chest pain will undergo standard assessment. This can include doctor’s assessment, blood tests including cardiac markers such as two troponin blood tests, xrays and CT scans. If the patient has been deemed as ‘low risk’ chest pain (i.e their troponin result is negative and/or other tests are negative) and are likely to be discharged, then they are usually admitted to ED Short stay area while awaiting the repeat troponin blood test in 2 hour’s time.

During the 2 hour period while patients are awaiting their repeat troponin eligible participants will be randomised to the intervention and control groups. The intervention group will undergo a single bedside cardiac ultrasound performed by an Emergency Physician trained in cardiac ultrasound or ED registrar with supervision by Emergency Physician. The ultrasound scan will be performed using Phillips Sparq Ultrasound Machine (Phased array probe) or similar point-of-care ultrasound device, and be performed using a documented protocol. Fidelity to the intervention will be monitored on review of each of the patient scans.

Both intervention and control groups will complete a satisfaction/feedback surveys prior to final discharge .
Intervention code [1] 320223 0
Diagnosis / Prognosis
Comparator / control treatment
The control group will undergo standard care - a standard assessment for low risk chest pain and then will complete the satisfaction survey
Control group
Active

Outcomes
Primary outcome [1] 327132 0
Primary outcome - Patient satisfaction scores.

Instrument used: is a patient satisfaction scoring system based on previous publications used to measure satisfaction with bedside ultrasound (Howard et al, J Emerg Med, 2014).
Timepoint [1] 327132 0
Both intervention and control groups will complete a satisfaction/feedback surveys prior to final discharge
Secondary outcome [1] 393908 0
No specific secondary outcomes
Timepoint [1] 393908 0
NA

Eligibility
Key inclusion criteria
Inclusion criteria
- Age greater than or equal to 18 years
- History of chest pain on presentation to ED
- Non-Trauma related chest pain
- Low risk chest pain (no new ECG changes, negative troponins, Musculoskeletal chest pain, chest pain due to Upper GI pathology)
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria
- Age < 18
- Trauma related chest pain
- Critically ill patients requiring urgent cardiac interventions
- Unable to consent or provide satisfaction feedback (e.g due to language barrier, refusal to provide consent, intoxicated, cognitive impairment etc)
- Patients who receive a formal cardiac ultrasound from cardiovascular and ICU labs

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation concealment will be used, with the group to which the subject will be allocated being in sealed packs
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The randomisation will occur En Bloc of 20 participants using the website program ‘Study Randomizer’ (https://studyrandomizer.com).
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
A sample size of 304 participants (152 participants in each group) will be recruited to the study. This is with a study power 0.8 calculated using PS: Power and sample size calculator. This is based on the local ED patient population i.e 71000 total presentations during 2017 of which 10000 were ‘low risk’ chest pain. This study will run until 304 eligible patients are recruited.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
1/04/2019
Date of last participant enrolment
Anticipated
31/12/2023
Actual
Date of last data collection
Anticipated
31/12/2023
Actual
Sample size
Target
304
Accrual to date
45
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 19079 0
Nepean Hospital - Kingswood
Recruitment hospital [2] 19080 0
Sydney Adventist Hospital - Wahroonga
Recruitment hospital [3] 19081 0
Royal Prince Alfred Hospital - Camperdown
Recruitment postcode(s) [1] 33635 0
2747 - Kingswood
Recruitment postcode(s) [2] 33636 0
2076 - Wahroonga
Recruitment postcode(s) [3] 33637 0
2050 - Camperdown

Funding & Sponsors
Funding source category [1] 308293 0
Hospital
Name [1] 308293 0
Nepean Hospital
Country [1] 308293 0
Australia
Funding source category [2] 308588 0
Hospital
Name [2] 308588 0
Sydney Adventist Hospital
Country [2] 308588 0
Australia
Primary sponsor type
Individual
Name
Dr Vijay Manivel
Address
Nepean Hospital, Derby St, Kingswood NSW 2747
Country
Australia
Secondary sponsor category [1] 309095 0
Individual
Name [1] 309095 0
Dr Shilpa Yashwanth Kumar
Address [1] 309095 0
Nepean Hospital, Derby St, Kingswood NSW 2747
Country [1] 309095 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308265 0
NEPEAN BLUE MOUNTAINS LOCAL HEALTH DISTRICT HUMAN RESEARCH ETHICS COMMITTEE
Ethics committee address [1] 308265 0
Ethics committee country [1] 308265 0
Australia
Date submitted for ethics approval [1] 308265 0
22/05/2018
Approval date [1] 308265 0
19/06/2018
Ethics approval number [1] 308265 0
2018 PID 139 ETH 140

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 110130 0
Dr Shilpa Yashwanth Kumar
Address 110130 0
Nepean Hospital ED, Derby St, Kingswood NSW 2747
Country 110130 0
Australia
Phone 110130 0
+61 02 4734 2763
Fax 110130 0
Email 110130 0
[email protected]
Contact person for public queries
Name 110131 0
Vijay Manivel
Address 110131 0
Nepean Hospital ED, Derby St, Kingswood NSW 2747
Country 110131 0
Australia
Phone 110131 0
+61 02 4734 2763
Fax 110131 0
Email 110131 0
[email protected]
Contact person for scientific queries
Name 110132 0
Vijay Manivel
Address 110132 0
Nepean Hospital ED, Derby St, Kingswood NSW 2747
Country 110132 0
Australia
Phone 110132 0
+61 02 4734 2000
Fax 110132 0
Email 110132 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
All of the individual participant data collected during the trial, after de-identification
When will data be available (start and end dates)?
Beginning 3 months and ending 5 years following main results publication
Available to whom?
case-by-case basis at the discretion of Primary Sponsor
Available for what types of analyses?
Only to achieve the aims in the approved proposal
How or where can data be obtained?
Access subject to approvals by Principal Investigator - email [email protected]


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.