|Primary registry and trial identifying number||Australian and New Zealand Trial Registration, ACTRN12618001442291|
|Date of registration||28 August 2018|
|Primary sponsor||Royal Melbourne Hospital|
|Public title||A bedside ultrasound in general medicine patients with cardiopulmonary diagnosis|
|Scientific title||A randomized trial of focused cardiac, lung, and femoral and vein ultrasound on the length of stay in internal medicine admissions with a cardiopulmonary diagnosis. IMFCU-1 study.|
|Date of first enrolment||3 September 2018|
|Target sample size||250|
|Recruiting status||Recruiting (103 recruited)|
|Study design||Randomized controlled trial parallel|
|Country of recruitment||Australia|
|Contacts||Prof Colin Royse (principal investigator)|
Address: Level 6, Centre of Medical Research, Royal Parade, Parkville, VIC 3052, Australia.
Affiliation: Department of Surgery, University of Melbourne
Department of Anesthesia and Pain Management, Royal Melbourne Hospital
|Key inclusion & exclusion criteria||Inclusion criteria:|
Adult patients (aged 18 years or older) admitted to general medicine unit at the Royal Melbourne Hospital with a cardiopulmonary diagnosis, expected to remain in hospital longer than 24 h.
Already admitted longer than 24 h
Admitted for social reasons rather than medical
Have received an echocardiography within four weeks before admission or a CT chest scan during the admission process before enrolment
|Health conditions or problems studied||Heart failure, asthma, COPD, pneumonia, PE, unspecified dyspnea|
|Intervention||A bedside ultrasound done by a physician trained in POCUS. The ultrasound takes around 20 min to be performed. The quality of the report will be assessed by a second expert who will check the images and videos recorded.|
|Primary outcome||LOS at the hospital|
|Secondary outcome||Incidence of new diagnosis and Incidence of changing management. These two outcomes will be assessed only in the interventional group. The treating physician will be asked to fill in a form with the initial diagnosis and plan of management. This form is a checklist 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 analyzed as “change of management” due to our intervention.|
Health costs: this outcome will be assessed by the sum of the following three components: (1) cost per day at the hospital; (2) cost of the pathology investigation; (3) cost of the imaging tests.