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Trial registered on ANZCTR


Registration number
ACTRN12613001023741
Ethics application status
Approved
Date submitted
11/09/2013
Date registered
13/09/2013
Date last updated
11/07/2019
Date data sharing statement initially provided
11/07/2019
Date results information initially provided
11/07/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Improving recognition of heart failure using lung ultrasound
Scientific title
Multicentre randomised controlled trial incorporating bedside lung ultrasound into the diagnosis of congestive cardiac failure in breathless older patients
Secondary ID [1] 283034 0
Nil
Universal Trial Number (UTN)
Trial acronym
LUS+2014
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Using bedside ultrasound to improve the recognition of heart failure in the emergency department 289868 0
Condition category
Condition code
Cardiovascular 290228 290228 0 0
Diseases of the vasculature and circulation including the lymphatic system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Breathless patients over 60 years old presenting to an emergency department will receive bedside lung ultrasound as part of the assessment phase of the breathlessness.

All participants in the trial will receive the standard emergency work-up for breathless.

The intervention group will also receive a bedside lung ultrasound.

The scan protocol for bedside lung ultrasound takes approximately 2 minutes to complete and involves taking 4 longitudinal images in both lungs.

The scan will be interpreted as demonstrating a 'wet' lung - consistent with pulmonary oedema - or a 'dry' lung which is inconsistent with pulmonary oedema.
Intervention code [1] 287754 0
Diagnosis / Prognosis
Comparator / control treatment
The patient will receive standard work-up for the investigation of the breathless patient. This can vary depending on the provisional diagnosis following history and examination, but includes arterial blood gas, chest Xray or CT pulmonary angiogram. Bedside lung ultrasound is not typically performed in the assessment phase currently.
Control group
Active

Outcomes
Primary outcome [1] 290249 0
The difference in diagnostic accuracy between the lung ultrasound augmented assessment and conventional assessment of breathlessness in the emergency department.

The interpretation of the lung ultrasound as wet (pulmonary oedema) or dry (not pulmonary oedema) will be compared to the CXR report and final diagnosis to examine diagnostic accuracy.
Timepoint [1] 290249 0
The data to evaluate this time point will be collected by a research assistant within a week of the patient's presentation, once a diagnosis for the breathlessness is available.
Secondary outcome [1] 304203 0
Sensitivity and specificity of lung ultrasound for the differentiation of breathlessness.

Again, the interpretation of the lung ultrasound as wet (pulmonary oedema) or dry (not pulmonary oedema) will be compared to the CXR report and final diagnosis to examine diagnostic accuracy.
Timepoint [1] 304203 0
The data to evaluate this time point will be collected by a research assistant within a week of the patient's presentation, once a diagnosis for the breathlessness is available.
Secondary outcome [2] 304595 0
Hospital length of stay will be obtainable from the electonic record.
Timepoint [2] 304595 0
Will be obtained by a research assistant within one week of the patient's discharge from hospital.
Secondary outcome [3] 304596 0
Proportion of cases where the Chest Xray contributed extra information above that contributed by the Lung US
Timepoint [3] 304596 0
The data to evaluate this time point will be collected by a research assistant within a week of the patient's presentation, once a diagnosis for the breathlessness is available.

Eligibility
Key inclusion criteria
Breathless patients presenting to the emergency department who are over 60 years old.
Minimum age
60 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
The patient is excluded if they are requiring active airway support, if they were involved in trauma or if there are any contagious lesion in the areas for scanning (eg shingles)

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
If the patient meets the inclusion criteria at triage, they are identified by the triage nurse and their details are placed in a screening logbook with the senior medical officer (SMO) being notified. The SMO will approach the patient or proxy and obtain informed consent to participate in the trial. If consenting the patient will be allocated to a registrar who has been taught the trial protocol who will select a randomisation envelope. If the patient is randomised to the intervention group, the registrar performs a lung scan early in the course of the episode of care and writes his or her impression of the scan in the trial book and in the patients notes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation envelopes contain 2 identical stickers with a trial code number and selection of control or intervention eg IP LUS 34 control. Randomisation will be determined using a simple randomisation table from a statistics book.
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
Demographic data will be used in non identifiable form to describe summary statistics of the population studied.
The data will be compared using qualitative statistical methods to give test statistics (diagnostic accuracy, sensitivity and specificity, positive and negative predictive values) for the use of basic bedside lung ultrasound by
inexperienced practitioners in the investigation of shortness of breath.

Sub group analysis will include the proportion of cases in which the diagnosis changed between lung ultrasound
result and chest xray will be calculated, and the proportion of cases where chest xray did not influence the diagnosis,
or where it appears to have adversely affected the diagnosis.
Multilinear regression analysis will be used to see if, when accounting for age, sex and severity of symptoms,
whether an incorrect diagnosis makes a significant effect on the length of stay in hospital.

Reanalysis of the deidentified scan sets may be used to test other diagnostic cut points that have been suggested
by other research groups.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 1501 0
Ipswich Hospital - Ipswich
Recruitment hospital [2] 1502 0
Princess Alexandra Hospital - Woolloongabba
Recruitment hospital [3] 1503 0
Royal Brisbane & Womens Hospital - Herston
Recruitment hospital [4] 1504 0
The Prince Charles Hospital - Chermside

Funding & Sponsors
Funding source category [1] 287938 0
Other Collaborative groups
Name [1] 287938 0
Queensland Emergency Medicine Research Fund
Address [1] 287938 0
Suite 5B, The Terrace Suites, 19 Lang Parade, Milton Qld 4064
Country [1] 287938 0
Australia
Primary sponsor type
Other Collaborative groups
Name
Queensland Emergency Medicine Research Fund
Address
Suite 5B, The Terrace Suites, 19 Lang Parade, Milton Qld 4064
Country
Australia
Secondary sponsor category [1] 286659 0
None
Name [1] 286659 0
NONE
Address [1] 286659 0
Country [1] 286659 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289867 0
Metro South Health Service District HREC (EC00167)
Ethics committee address [1] 289867 0
Ethics committee country [1] 289867 0
Australia
Date submitted for ethics approval [1] 289867 0
Approval date [1] 289867 0
08/08/2013
Ethics approval number [1] 289867 0
HREC/13/QPAH/285

Summary
Brief summary
This project aims to improve patient care by putting evidence into practice. Secondary gains include improving ultrasound practices, establishing robust predictive values,and eventually reducing certain unnecessary xrays. This technique, once validated, will be of particular use in regional Australia.

Many older persons present to the emergency department complaining of breathlessness. This can be an important
forewarning of heart failure, but is present in many conditions. In most cases, several tests are carried out to identify those patients with heart failure. Despite these investigations, heart failure is initially misdiagnosed in up to one quarter of patients. The interpretation of chest xray by treating physicians is notoriously fallible.

Many European hospitals use bedside lung ultrasound(LUS) to improve their recognition of heart failure, but as the
European practice model is significantly different from the Australian, the practice is not common here. The method
is cheap, rapid, safe, readily available and causes trivial interference to current management.

Our pilot study has already tested the lung ultrasound method in parallel with conventional investigation, without
allowing it to influence management. Now we aim to incorporate it within the testing paradigm, by unblinding the
treating doctor.

We wish to see if the augmented assessment paradigm has a superior diagnostic accuracy to the conventional assessment paradigm. We will start by teaching a cohort of emergency trainee doctors to perform the test. Older patient who present with breathlessness to the ED will be randomised to either conventional or augmented investigation paradigm, track the emergency doctor's diagnosis after lung scan and again after full workup, and then compare the accuracy of these diagnosed in each group against a reference standard of delayed expert chart audit (which includes all prior and subsequent tests and course of disease).

The primary endpoint is the difference in diagnostic accuracy between the LUS augmented investigation and the
conventional investigation of breathlessness in the emergency department. Secondary endpoints are the sensitivity and specificity of LUS for differentiation of breathlessness. Exploratory endpoints will be the difference in length of stay in hospital between the groups, and the proportion of cases where chest xray contributed extra informationabove that contributed by the LUS.


Trial website
Is currently under construction, but is intended to be a facebook page.
Trial related presentations / publications
It is intended to publish several papers from this research, in emergency medicine journals and via open access
publishing.Findings will be presented at local,national and international meetings. Information will be used to
improve teaching at workshops.
Public notes

Contacts
Principal investigator
Name 42214 0
Dr Kylie Baker
Address 42214 0
Ipswich General Hospital Emergency Department
Chelmsford Ave
Ipswich Qld 4305
Country 42214 0
Australia
Phone 42214 0
+617 38101111
Fax 42214 0
Email 42214 0
kyliebaker888@bigpond.com
Contact person for public queries
Name 42215 0
Dr Kylie Baker
Address 42215 0
Ipswich General Hospital Emergency Department
Chelmsford Ave
Ipswich Qld 4305
Country 42215 0
Australia
Phone 42215 0
+61738101111
Fax 42215 0
Email 42215 0
kyliebaker888@bigpond.com
Contact person for scientific queries
Name 42216 0
Dr Kylie Baker
Address 42216 0
Ipswich General Hospital Emergency Department
Chelmsford Ave
Ipswich Qld 4305
Country 42216 0
Australia
Phone 42216 0
+617 38101111
Fax 42216 0
Email 42216 0
kyliebaker888@bigpond.com

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No/undecided IPD sharing reason/comment
What supporting documents are/will be available?
Summary results
Have study results been published in a peer-reviewed journal?
Yes
Journal publication details
Publication date and citation/details [1] 2974 0
Accepted 20/5/19

Baker K, Brierley S, Kinnear F, Isoardi K, Livesay G, Stieler G and Mitchell G. Implementation study reporting diagnostic accuracy, outcomes and costs in a multi centre RCT of non-expert lung ultrasound to detect pulmonary oedema. Emergency Medicine Australasia 2019; doi: 10.1111/1742-6723.13333
Other publications
Have study results been made publicly available in another format?
No
Results – basic reporting
Results – plain English summary
Non-expert lung ultrasound augmenting dyspnoea workup may improve diagnostic accuracy, but did not significantly alter costs or outcomes in the ED or the hospital.