Preoperative focused echocardiography on patients with fractured neck of femur. ECHONOF-III trial: study protocol for a multicenter randomized controlled trial

Background: Hip fractures are common in older people and are associated with high perioperative mortality. Prompt surgical intervention within the first 48 h of fraction reduces complications; however, surgical urgency often precludes a comprehensive preoperative cardiac evaluation. Preliminary data suggests that performing a focused cardiac ultrasound (FCU) before surgery may reduce postoperative complications. We therefore propose to test the primary hypothesis that FCU reduces a 30-day composite of mortality and serious complications. Methods: We plan a definitive multicenter pragmatic randomized trial that will enroll 2000 adults with hip fractures. Participants will be randomized before surgery to either receive FCU as part of their preoperative assessment or to routine care without FCU. FCU is a brief, 10-min, goal-directed echocardiography performed at the patient’s bedside. FCU will be conducted by physicians trained in FCU and the information gathered will be shared immediately with all clinicians involved in the patient’s care (anesthesiologists, orthopedic surgeons, geriatricians). The primary outcome will be a 30-day composite of all-cause mortality, hospital readmission, acute kidney injury, cardiac failure, and myocardial injury after noncardiac surgery. Secondary and exploratory outcomes include hospital length of stay, days to return to original residence, postoperative recovery, and quality of life. Additionally, a health cost analysis will be conducted to weigh costs against benefits. Discussion: Our large RCT aims to determine whether preoperative focused ultrasound examinations of hip fracture patients reduce serious postoperative complications, improves the quality of recovery, improves life quality, and is cost-effective.