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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Melbourne
- Enrollment
- 100
- Locations
- 4
- Primary Endpoint
- Composite mortality and morbidity score
Study Overview
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.
Detailed Description
Aims and Hypotheses Aims
- To determine whether routine preoperative focused cardiac ultrasound (FCU) leads to a reduced composite outcome of death, major adverse cardiac events, and acute renal failure (adverse composite outcome) 30 days after hip fracture surgery compared to patients who do not receive preoperative FCU (current standard of care).
- To identify the changes in team management of the patient due to FCU that are associated with improved outcome, compared to current standard of care.
- To determine whether routine preoperative FCU is more cost-effective than current standard of care.
Hypotheses
- FCU reduces adverse composite outcome by at least 20%, 30 days after hip fracture surgery.
- FCU leads to changes in cardiac diagnosis, and subsequent changes to perioperative and post-discharge management plans, which are associated with improved outcome compared to current standard of care.
- Routine FCU before hip fracture surgery is more cost-effective than current standard of care.
Identifying cardiovascular disease: Preoperative cardiac assessment, which enables improved cardiac treatment and reduction of cardiac complications, is recommended by the American Heart Association. However, cardiovascular disease is often unrecognised and under-diagnosed in this age group because of frailty, general immobility, and the high frequency of poor cognitive function including dementia, which inhibits accurate clinical assessment. Careful cardiac assessment and treatment is often not undertaken because of the belief that surgery should be performed urgently and a delay for cardiac investigations may worsen outcome.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Diagnostic
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
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.
Arms & Interventions
Focused Cardiac Ultrasound
participants randomised to receive focused cardiac ultrasound prior to surgery for hip fracture
Intervention: Focused cardiac ultrasound (Other)
Standard care (clinical assessment)
Participants randomised to standard care receive clinical assessment of the patient
Outcomes
Primary Outcomes
Composite mortality and morbidity score
Time Frame: 30 days after surgery
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.
Secondary Outcomes
- The number of days alive, out of hospital, and until return to place of origin(12 months)
- Changes in clinician diagnosis and management from a recorded preoperative plan(30 days)
- Total cost of care(12 months)
- EuroQol Health status score(12 months)
Investigators
Colin Royse
Professor of Anaesthesia
University of Melbourne