Trial Review

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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] 295740 0
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 309139 0
Pneuomonia 309193 0
chronic obstructive pulmonary disease 309194 0
asthma 309195 0
pulmonary embolism 309196 0
unspecified dyspnea 309197 0
Condition category
Condition code
Respiratory 308019 308019 0 0
Asthma
Cardiovascular 308020 308020 0 0
Other cardiovascular diseases
Respiratory 308253 308253 0 0
Asthma
Respiratory 308255 308255 0 0
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] 312066 0
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] 307012 0
Length of stay at the hospital.
The data will be collected from hospital records.
Timepoint [1] 307012 0
Discharge from the hospital
Secondary outcome [1] 350349 0
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] 350349 0
First 24 hours at the general medicine unit.
Secondary outcome [2] 350461 0
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] 350461 0
Discharge from hospital
Secondary outcome [3] 350462 0
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] 350462 0
First 24 hours at the general medicine unit
Secondary outcome [4] 371262 0
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] 371262 0
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?
No
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] 11591 0
Royal Melbourne Hospital - City campus - Parkville
Recruitment postcode(s) [1] 23635 0
3050 - Parkville

Funding & Sponsors
Funding source category [1] 300331 0
Hospital
Name [1] 300331 0
Royal Melbourne Hospital
Country [1] 300331 0
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] 299970 0
None
Name [1] 299970 0
Address [1] 299970 0
Country [1] 299970 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301142 0
Melbourne Health Human Research Ethics Committee
Ethics committee address [1] 301142 0
Ethics committee country [1] 301142 0
Australia
Date submitted for ethics approval [1] 301142 0
30/05/2018
Approval date [1] 301142 0
27/06/2018
Ethics approval number [1] 301142 0
HREC/18/MH/269

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

Contacts
Principal investigator
Name 85998 0
Prof Colin Royse
Address 85998 0
Level 6, Centre of Medical Research
Royal Parade
Parkville
VIC 3052
Country 85998 0
Australia
Phone 85998 0
+61383445673
Fax 85998 0
Email 85998 0
[email protected]
Contact person for public queries
Name 85999 0
Colin Royse
Address 85999 0
Level 6, Centre of Medical Research
Royal Parade
Parkville
VIC 3052
Country 85999 0
Australia
Phone 85999 0
+61383445673
Fax 85999 0
Email 85999 0
[email protected]
Contact person for scientific queries
Name 86000 0
Colin Royse
Address 86000 0
Level 6, Centre of Medical Research
Royal Parade
Parkville
VIC 3052
Country 86000 0
Australia
Phone 86000 0
+61383445673
Fax 86000 0
Email 86000 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?
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
SourceTitleYear of PublicationDOI
EmbaseImpact 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.2020https://dx.doi.org/10.1186/s13063-019-4003-2
EmbaseAutomatic deep learning-based pleural effusion classification in lung ultrasound images for respiratory pathology diagnosis.2021https://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.