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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 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]

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

Condition category

Condition code

Cardiovascular

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]

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]

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]

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]

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]

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]

Hospital length of stay will be obtainable from the electonic record.

Timepoint [2]

Will be obtained by a research assistant within one week of the patient's discharge from hospital.

Secondary outcome [3]

Proportion of cases where the Chest Xray contributed extra information above that contributed by the Lung US

Timepoint [3]

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

Sex

Both males and females

Can healthy volunteers participate?

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

30/09/2013

Actual

30/09/2013

Date of last participant enrolment

Anticipated

30/09/2015

Actual

31/10/2016

Date of last data collection

Anticipated

Actual

31/10/2016

Sample size

Target

300

Accrual to date

Final

485

Recruitment in Australia

Recruitment state(s)

QLD

Recruitment hospital [1]

Ipswich Hospital - Ipswich

Recruitment hospital [2]

Princess Alexandra Hospital - Woolloongabba

Recruitment hospital [3]

Royal Brisbane & Womens Hospital - Herston

Recruitment hospital [4]

The Prince Charles Hospital - Chermside

Funding & Sponsors

Funding source category [1]

Other Collaborative groups

Name [1]

Queensland Emergency Medicine Research Fund

Address [1]

Suite 5B, The Terrace Suites, 19 Lang Parade, Milton Qld 4064

Country [1]

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]

None

Name [1]

NONE

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Metro South Health Service District HREC (EC00167)

Ethics committee address [1]

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

08/08/2013

Ethics approval number [1]

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

Dr Kylie Baker

Address

Ipswich General Hospital Emergency Department
Chelmsford Ave
Ipswich Qld 4305

Country

Australia

Phone

+617 38101111

Fax

kyliebaker888@bigpond.com

Contact person for public queries

Name

Kylie Baker

Address

Ipswich General Hospital Emergency Department
Chelmsford Ave
Ipswich Qld 4305

Country

Australia

Phone

+61738101111

Fax

kyliebaker888@bigpond.com

Contact person for scientific queries

Name

Kylie Baker

Address

Ipswich General Hospital Emergency Department
Chelmsford Ave
Ipswich Qld 4305

Country

Australia

Phone

+617 38101111

Fax

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?

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

Source	Title	Year of Publication	DOI
Embase	Implementation study reporting diagnostic accuracy, outcomes and costs in a multicentre randomised controlled trial of non-expert lung ultrasound to detect pulmonary oedema.	2020	https://dx.doi.org/10.1111/1742-6723.13333

N.B. These documents automatically identified may not have been verified by the study sponsor.

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Documents added manually

Documents added automatically