DysPOCUS trial dataset
The University of MelbourneDataset description
The dataset will include demographic and relevant health data for 900 participants enrolled in the DysPOCUS trial. Participants will include individuals of all genders, aged 65 years and older, who are admitted to hospital with dyspnoea. Relevant health data will include vital signs, medical history, basic physical examination findings, outcomes from the modified Borg Dyspnoea Scale, the Lawton and Brody IADL survey, and the EQ-5D-5L. Participant involvement will be considered complete upon completion of the one-year follow-up. The trial dataset will only become available after the conclusion of the study, which is anticipated to occur in late 2030.Date Information
Subjects
Cardiology (incl. cardiovascular diseases) | Clinical chemistry (incl. diagnostics) | Emergency medicineIdentifiers
Source Study
Trial name (public)
Purpose:
Phase:
Trial acronym
Not available
Trial ID
ACTRN12626000270314
Funding
Government body, Department of Health, Disability and Ageing - MRFF 2023 Clinical Trials Activity Stream 2
Scientific enquiries
Ximena Cid Serra
Brief Summary
A multicentre, randomised parallel group, open superiority trial. 900 patients 65 years old or older admitted to the general medicine ward with a primary presentation of dyspnoea will be allocated in a 1:1 ratio to receive a) usual care or b) usual care and POCUS of the heart, lungs and proximal lower limb veins, performed within 24 hours of ward admission. The main outcome assessed in length of hospital stay. Secondary outcomes include dyspnoea improvement, mortality and major adverse cardiovas .... Read more
Key Inclusion Criteria
Adults aged 65 years or older who are admitted to the internal medicine ward where the primary symptom leading to admission is dyspnoea regardless of the initial medical diagnosis (e.g decompensated heart failure, pneumonia, asthma)
Key Exclusion Criteria
Exclusion criteria include having a computed tomography chest or CT pulmonary angiogram, point of care ultrasound performed by emergency physicians, being admitted to the ward more than 24 hours ago, or where death is expected within 48-hour.
Can healthy volunteers participate?
No
Population
Sample Size 900
Min. age 65 Years
Max. age No limit
Sex Both males and females
Condition category dyspnoea , heart failure , acute respiratory failure , chronic obstructive pulmonary disease
Condition code Cardiovascular , Respiratory
Intervention
Intervention code Diagnosis / Prognosis , Treatment: Other
Point of care ultrasound of the heart, lungs, and proximal lower limb veins will be performed once by a physician within the first 24 hours of hospital admission. The examination takes approximately 15 minutes on average and involves the use of a portable ultrasound machine with acoustic gel. The ultrasound transducer is placed over the patient’s chest, posterior thorax, and proximal lower limbs to obtain the required views. A structured report of the examination will be collected to assess adhe .... Read more
Comparison
Control group Active
Usual care, for the purposes of this trial, is defined as standard clinical assessment performed by the treating team, including medical history, physical examination, laboratory investigations, and formal imaging studies requested through the Department of Radiology or the Echocardiography Laboratory. Usual care does not include point-of-care ultrasound.
Outcomes
Outcome: Length of hospital stayTimepoint: At hospital discharge
Will the study consider sharing individual participant data?
Yes
Who can request access to individual participant data?
Researchers
Are there any conditions for requesting access to individual participant data?
Yes, conditions apply
Requires review on a case-by-case basis by the trial custodian, sponsor or data sharing committee
Requires a scientifically sound proposal or protocol
Requires approval by an ethics committee
Requires a data sharing agreement between data requester and trial custodian or sponsor
What individual participant data might be shared?
De-identified individual participant data
Primary outcome(s)
What types of analyses could be done with individual participant data?
Systematic reviews and meta-analyses
Health economic analyses
Are there extra considerations when requesting access to individual participant data?
No
When can request for individual data be made (start and end dates)?
From: After publication of main results
To: Not yet decided