None listed
Conditions
Brief summary
ECHONOF III is a parallel group, pragmatic randomised controlled multi-centre trial, in which patients presenting with hip fracture are randomised to receive or not receive preoperative focused transthoracic echocardiography (TTE) before surgery. The trial aims to assess whether adding a focused TTE will lead to a reduced composite outcome of at least one of: all-cause mortality, cardiac failure, myocardial injury in noncardiac surgery, acute kidney injury or hospital readmission at 30 days post-surgery compared to patients who do not receive preoperative focused TTE (the current standard of care). A sample size of 2,000 patients has been estimated (1,000 per group). Secondary outcomes include in-hospital medical complications, quality of recovery, independent living and health cost analysis.
Interventions
The intervention is a Focused Transthoracic Echocardiography (TTE) in addition to the standard pre-operative evaluation. It is performed before surgery by a doctor (anaesthetist, internal medicine physician, surgeon or cardiologist) proficient in point-of-care ultrasound and trained in the University of Melbourne iHeartScan protocol.
The focused TTE is performed at the bedside of the patient and takes up to 15 minutes to be completed. The test involves a brief assessment of the left and right
The intervention is a Focused Transthoracic Echocardiography (TTE) in addition to the standard pre-operative evaluation. It is performed before surgery by a doctor (anaesthetist, internal medicine physician, surgeon or cardiologist) proficient in point-of-care ultrasound and trained in the University of Melbourne iHeartScan protocol. The focused TTE is performed at the bedside of the patient and takes up to 15 minutes to be completed. The test involves a brief assessment of the left and right ventricles' size and function, significant cardiac valve abnormalities (stenosis and regurgitation), presence of pericardial effusion and indirect signs of diastolic left ventricle dysfunction. A written report will be available to the anaesthetist performing the pre-operative assessment and the medical team involved in the patient care (orthopaedics, ortho- geriatricians and general medicine physicians). The intervention is delivered in a single time-point (before surgery); therefore, strategies to monitor adherence are not required.
Sponsors
Melbourne health
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Diagnosis
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Patients presenting with isolated, primary, non-metastatic fractured neck of femur surgery is expected within 48 hours after hospital admission
Exclusion criteria
Prior hip surgery on the affected side Likely metastatic cancer Survival is unlikely in the 24 hours from admission Having an echocardiography done in the last 30 days
Outcome results
None listed