ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12618001442291

Ethics application status

Approved

Date submitted

8/08/2018

Date registered

28/08/2018

Date last updated

14/10/2021

Date data sharing statement initially provided

16/04/2019

Type of registration

Prospectively registered

Titles & IDs

Public title

A bedside ultrasound in general medicine patients with cardiopulmonary diagnosis.

Scientific title

A randomised trial of focused cardiac, lung, and femoral and popliteal vein ultrasound on the length of stay in internal medicine admissions with a cardiopulmonary diagnosis.

Secondary ID [1]

Nil known

Universal Trial Number (UTN)

U111112185271

Trial acronym

IMFCU-1

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Heart failure

Pneuomonia

chronic obstructive pulmonary disease

asthma

pulmonary embolism

unspecified dyspnea

Condition category

Condition code

Respiratory

Asthma

Cardiovascular

Other cardiovascular diseases

Respiratory

Asthma

Respiratory

Chronic obstructive pulmonary disease

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

A bedside ultrasound done by a physician trained in focused ultrasonography.
The ultrasound involves scan of the heart, lungs and two lower extremity veins (femoral and popliteal). All the patients allocated to the interventional group will receive the same ultrasound examination. The study takes around 20 minutes to be performed.
The quality of the technique will be assess by an expert in echocardiography and bedside ultrasound, who will check the images and videos recorded. Additionally, if the patient goes to a formal investigation (echocardiography or CT chest scan), the results of the bedside ultrasound will be cross checked with the report of these tests.

Intervention code [1]

Diagnosis / Prognosis

Comparator / control treatment

Standard management.

By standard management we mean the treatment and further investigations that treating physicians decide based on their usual clinical evaluation, which does not include a bedside ultrasound. It is not based upon any specific guideline.

Control group

Active

Outcomes

Primary outcome [1]

Length of stay at the hospital.
The data will be collected from hospital records.

Timepoint [1]

Discharge from the hospital

Secondary outcome [1]

The incidence of change of medical management.

This outcome will be assessed only in the interventional group.
The treating physician will be asked to fill a form with the initial diagnosis and plan of management. This form is a check list describing further investigations (blood test and imaging), consultation to another specialist and medication prescribed (diuretics, antibiotics, etc).
After performing and revealing to them the findings of the bedside ultrasound, the treating physician will be asked to fill a second form that is exactly the same than the first one. The difference between both will be analysed as "change of management" due to our intervention.

Timepoint [1]

First 24 hours at the general medicine unit.

Secondary outcome [2]

Health costs (a composite outcome)

This outcome will be assessed by the sum of the following three components:
1.- Cost per day at the hospital: To assess this item we are collecting from the hospital record the number of days that the patient stayed at the hospital specifying every unit where they stayed. Then, this number is multiply by the value of one day at the hospital (data that we already have from the hospital administration)..
2.- Cost of the pathology investigations: we are collecting from the hospital record the number and type of pathology investigations performed during the stay at the hospital . We calculate the total cost in this item based on the list of prices used by the hospital administration.
3.- Cost of the imaging tests: we are collecting from the hospital record the number and type of imaging tests performed during the stay at the hospital . We calculate the total cost in this item based on the list of prices used by the hospital administration.

The results from both groups will be compared.

Timepoint [2]

Discharge from hospital

Secondary outcome [3]

The incidence of new diagnosis

This outcome will be assessed only in the interventional group, in which a form about the diagnosis suspicion will be filled by the treating team before the ultrasound is performed, After the findings of the ultrasound examination are revealed to the treating team, they will be asked to fill a second form identical to the first one. Difference between both will traduce the effect of the intervention. The result will be shown as percentage of new diagnoses that were not proposed before the ultrasound.

Timepoint [3]

First 24 hours at the general medicine unit

Secondary outcome [4]

Readmission to the hospital during the next 30 days. This data will be gathered from the hospital record. Planned readmission will be excluded, only readmission through the Emergency Department will be recorded.

Timepoint [4]

30 days after hospital discharge.

Eligibility

Key inclusion criteria

Adult patients admitted to a general medicine unit at the Royal Melbourne Hospital with a cardiopulmonary diagnosis and are expected to remain in hospital longer than 24 hours

Minimum age

18 Years

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

Already admitted for longer than 24 hours
Admitted for social reasons rather than medical
Have received a transthoracic echocardiography within 4 weeks prior admission or a CT chest scan during the admission process prior to enrolment.

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)

yes, using sealed opaque envelopes.

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Block randomisation in unequal block sizes created by computer software

Masking / blinding

Open (masking not used)

Who is / are masked / blinded?

Intervention assignment

Parallel

Other design features

Phase

Not Applicable

Type of endpoint/s

Statistical methods / analysis

No censoring will be used for length of hospital stay. The primary outcome will be analyzed using Student’s t-test on the log transformed LOS data in hours. Secondary outcomes will be analysed using ordinary linear model as which considers other factors and their impact on length of stay, as well as parametric or non-parametric tests according to the type of data, whether the data is skewed, and whether repeated measures are used. For secondary endpoints, significance will be defined as p<0.01 to reduce the risk of Type 1 error.

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

31/08/2018

Actual

3/09/2018

Date of last participant enrolment

Anticipated

31/07/2019

Actual

1/01/2020

Date of last data collection

Anticipated

29/08/2019

Actual

30/11/2020

Sample size

Target

250

Accrual to date

Final

250

Recruitment in Australia

Recruitment state(s)

VIC

Recruitment hospital [1]

Royal Melbourne Hospital - City campus - Parkville

Recruitment postcode(s) [1]

3050 - Parkville

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

Royal Melbourne Hospital

Address [1]

Royal Melbourne Hospital
300 Grattan St. - Parkville
VIC 3050

Country [1]

Australia

Primary sponsor type

Hospital

Name

Royal Melbourne Hospital

Address

Royal Melbourne Hospital
300 Grattan St. - Parkville
VIC 3050

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Melbourne Health Human Research Ethics Committee

Ethics committee address [1]

Office for Research, Melbourne Health
Level 2 South-West, 300 Grattan Street PARKVILLE VIC 3050

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

30/05/2018

Approval date [1]

27/06/2018

Ethics approval number [1]

HREC/18/MH/269

Summary

Brief summary

The project investigates the clinical impact of adding a basic bedside ultrasound examination to the standard clinical evaluation of patients admitted to a General Medicine wards with symptoms reflecting a cardiac or respiratory problem.

It is a randomised trial. Randomisation means that patients will be assigned in one of the groups by  a method similar to flipping a coin, uncontrolled by the researcher. 
In this study participants will be randomised and allocated into two groups.  One group will receive a focused ultrasound examination of the heart, lung and lower extremity veins, performed by a general physician during the first 24 hours at the unit. This test takes around 20 minutes to be completed and it does not add any risk to the patient.  The result of the ultrasound will be given to the treating physician, who will decide the treatment and further investigations. The second group will receive standard care, in which a bedside ultrasound examination is not part of usual practice.

We will compare the length of stay at the hospital in both groups. We are expecting that this focused ultrasound will improve the work-flow by helping physician narrow down the possible diagnoses faster and guiding management. This may result in reduced length of stay. We aim to see if length of stay at the hospital can be reduced by 24 hours.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Prof Colin Royse

Address

Level 6, Centre of Medical Research
Royal Parade
Parkville
VIC 3052

Country

Australia

Phone

+61383445673

Fax

colin.royse@heartweb.com

Contact person for public queries

Name

Colin Royse

Address

Level 6, Centre of Medical Research
Royal Parade
Parkville
VIC 3052

Country

Australia

Phone

+61383445673

Fax

colin.royse@heartweb.com

Contact person for scientific queries

Name

Colin Royse

Address

Level 6, Centre of Medical Research
Royal Parade
Parkville
VIC 3052

Country

Australia

Phone

+61383445673

Fax

colin.royse@heartweb.com

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

Yes

What data in particular will be shared?

De-identified Demographic, primary and secondary outcomes data

When will data be available (start and end dates)?

After publication (3 months - no end date)

Available to whom?

researchers who provide a methodologically sound proposal,

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, requirement to sign data access agreement,

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	Impact of point-of-care ultrasound on the hospital length of stay for internal medicine inpatients with cardiopulmonary diagnosis at admission: Study protocol of a randomized controlled trial - The IMFCU-1 (Internal Medicine Focused Clinical Ultrasound) study.	2020	https://dx.doi.org/10.1186/s13063-019-4003-2
Embase	Automatic deep learning-based pleural effusion classification in lung ultrasound images for respiratory pathology diagnosis.	2021	https://dx.doi.org/10.1016/j.ejmp.2021.02.023

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