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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02629484




Registration number
NCT02629484
Ethics application status
Date submitted
1/12/2015
Date registered
14/12/2015
Date last updated
2/05/2018

Titles & IDs
Public title
Trial of Focused Cardiac Ultrasound for Fractured Neck of Femur Surgery
Scientific title
A Pilot Study to Assess Feasibility, Compliance, Safety and Group Separation for a Multicentre Randomised Trial of Preoperative Focused Cardiac Ultrasound for Fractured Neck of Femur Surgery
Secondary ID [1] 0 0
2015.231
Universal Trial Number (UTN)
Trial acronym
ECHONOFII
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hip Fractures 0 0
Condition category
Condition code
Injuries and Accidents 0 0 0 0
Fractures
Musculoskeletal 0 0 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - Focused cardiac ultrasound

Active Comparator: Focused Cardiac Ultrasound - participants randomised to receive focused cardiac ultrasound prior to surgery for hip fracture

No Intervention: Standard care (clinical assessment) - Participants randomised to standard care receive clinical assessment of the patient


Other interventions: Focused cardiac ultrasound
focused cardiac ultrasound is a goal-focused transthoracic echocardiography examination of the heart, aimed to improve the diagnostic accuracy of clinical assessment

Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Composite mortality and morbidity score - The primary outcome is 30 day composite outcome of the incidence of mortality, acute kidney injury, and cardiovascular morbidity (including non-fatal myocardial infarction, stroke, pulmonary embolism or cardiac arrest.
Timepoint [1] 0 0
30 days after surgery
Secondary outcome [1] 0 0
The number of days alive, out of hospital, and until return to place of origin - Longitudinal measures include the number of days alive, out of hospital and returning to their place of origin out to 12 months.
Timepoint [1] 0 0
12 months
Secondary outcome [2] 0 0
Changes in clinician diagnosis and management from a recorded preoperative plan - The treating doctors will complete a diagnosis and management research form prior to revealing the FCU findings or not. The actual management of the patient after allocation will be recorded prospectively for all patients, with the data recording sheets not showing allocation. Data include cardiac monitoring and treatment preoperatively, intraoperatively and postoperatively, including type of anaesthesia, fluid therapy, inotropes, other invasive organ support and intensive care use, surgical technique, and additional cardiovascular management post-hospital discharge.
Timepoint [2] 0 0
30 days
Secondary outcome [3] 0 0
Total cost of care - Units of health care resources consumed will be combined with Australian unit costs derived from Pharmaceutical benefit schedule, Medicare and Australian Diagnostic group indicators. The dollar value for each component of stay (e.g. days in hospital, drugs used, investigations performed) will be converted into a cost value and aggregated to make a single cost over the 12 month follow up period
Timepoint [3] 0 0
12 months
Secondary outcome [4] 0 0
EuroQol Health status score - The EuroQol health status survey instrument is a a standard, internationally validated instrument with Australian population norms, will be conducted at 12 months follow up
Timepoint [4] 0 0
12 months

Eligibility
Key inclusion criteria
- Patients presenting with isolated, primary, non-metastatic fractured neck of femur,
where surgery is expected within 48 hours after hospital admission will be recruited.
Minimum age
No limit
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Patients with prior hip surgery on the affected side, or where the cause is likely to
be due to metastatic cancer, or where survival is unlikely in the 24 hours from
admission will not be included.

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD,VIC
Recruitment hospital [1] 0 0
Prince Charles Hospital - Brisbane
Recruitment hospital [2] 0 0
Royal Melbourne Hospital - Melbourne
Recruitment hospital [3] 0 0
Western and Sunshine General hospitals - Melbourne
Recruitment postcode(s) [1] 0 0
- Brisbane
Recruitment postcode(s) [2] 0 0
3050 - Melbourne
Recruitment postcode(s) [3] 0 0
- Melbourne

Funding & Sponsors
Primary sponsor type
Other
Name
University of Melbourne
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Melbourne Health
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Austin Health
Address [2] 0 0
Country [2] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Hip fracture surgery is a major world health care burden and concern, as it has a large and
increasing prevalence and carries very high patient mortality, disability and community
health care cost. As the commonest cause of mortality is from cardiac complications, and
cardiac disease is prevalent and frequently missed by standard care, we hypothesise that
earlier and more accurate diagnosis and treatment of cardiac pathology in this cohort will
lead to improved outcome. Focused cardiac ultrasound (FCU) is a new increasingly popular
technique used by doctors that enables earlier and more accurate diagnosis of cardiac
disorders that can be performed routinely before hip fracture surgery. Our preliminary data
of 64 patients demonstrated that routine FCU before surgery lead to a change in cardiac
diagnosis and management in 50% of patients requiring hip fracture surgery, which was
associated with a 50% reduction in mortality 12 months after surgery compared with controls.
It is therefore important for a large randomised trial to be performed to confirm or rebuke
these findings, as if true, would have a very large impact on health care and may also
improve health care and outcome in other high-risk surgical populations. The proposed pilot
study is a pilot study which aims to establish feasibility, safety, compliance and group
separation prior to commencing a definitive multicentre trial.
Trial website
https://clinicaltrials.gov/show/NCT02629484
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Colin Royse, MD, BS
Address 0 0
University of Melbourne
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications