Ximena Cid-Serra, Alistair Royse, Andrea Bowyer, David Canty, Daniel Sessler, Sandy Clarke-Errey, Andre Denault, Dina LoGiudice, Guy Ludbrook, D-Yin Lin, Yang Yang, Kavi Haji, Lisa Zucherrelli, Andrew J Palmer, Benjamin Piper, Thar Nyan Lwin, Stefan Dieleman, David Eccleston, Alwin Chuan, Richard Cooper, Gregory Henderson, Colin Royse
{"title":"股骨颈骨折患者术前超声心动图分析。ECHONOF-III试验:多中心随机对照试验的研究方案。","authors":"Ximena Cid-Serra, Alistair Royse, Andrea Bowyer, David Canty, Daniel Sessler, Sandy Clarke-Errey, Andre Denault, Dina LoGiudice, Guy Ludbrook, D-Yin Lin, Yang Yang, Kavi Haji, Lisa Zucherrelli, Andrew J Palmer, Benjamin Piper, Thar Nyan Lwin, Stefan Dieleman, David Eccleston, Alwin Chuan, Richard Cooper, Gregory Henderson, Colin Royse","doi":"10.1186/s13063-025-09060-w","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>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.</p><p><strong>Methods: </strong>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.</p><p><strong>Discussion: </strong>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.</p><p><strong>Trial registration: </strong>Registration number: ACTRN12622001546741. Date registered 14/12/2022.</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":"26 1","pages":"333"},"PeriodicalIF":2.0000,"publicationDate":"2025-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12403293/pdf/","citationCount":"0","resultStr":"{\"title\":\"Preoperative focused echocardiography on patients with fractured neck of femur. ECHONOF-III trial: study protocol for a multicenter randomized controlled trial.\",\"authors\":\"Ximena Cid-Serra, Alistair Royse, Andrea Bowyer, David Canty, Daniel Sessler, Sandy Clarke-Errey, Andre Denault, Dina LoGiudice, Guy Ludbrook, D-Yin Lin, Yang Yang, Kavi Haji, Lisa Zucherrelli, Andrew J Palmer, Benjamin Piper, Thar Nyan Lwin, Stefan Dieleman, David Eccleston, Alwin Chuan, Richard Cooper, Gregory Henderson, Colin Royse\",\"doi\":\"10.1186/s13063-025-09060-w\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>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.</p><p><strong>Methods: </strong>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.</p><p><strong>Discussion: </strong>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.</p><p><strong>Trial registration: </strong>Registration number: ACTRN12622001546741. Date registered 14/12/2022.</p>\",\"PeriodicalId\":23333,\"journal\":{\"name\":\"Trials\",\"volume\":\"26 1\",\"pages\":\"333\"},\"PeriodicalIF\":2.0000,\"publicationDate\":\"2025-09-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12403293/pdf/\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Trials\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1186/s13063-025-09060-w\",\"RegionNum\":4,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q3\",\"JCRName\":\"MEDICINE, RESEARCH & EXPERIMENTAL\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Trials","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1186/s13063-025-09060-w","RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q3","JCRName":"MEDICINE, RESEARCH & EXPERIMENTAL","Score":null,"Total":0}
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.
Trial registration: Registration number: ACTRN12622001546741. Date registered 14/12/2022.
期刊介绍:
Trials is an open access, peer-reviewed, online journal that will encompass all aspects of the performance and findings of randomized controlled trials. Trials will experiment with, and then refine, innovative approaches to improving communication about trials. We are keen to move beyond publishing traditional trial results articles (although these will be included). We believe this represents an exciting opportunity to advance the science and reporting of trials. Prior to 2006, Trials was published as Current Controlled Trials in Cardiovascular Medicine (CCTCVM). All published CCTCVM articles are available via the Trials website and citations to CCTCVM article URLs will continue to be supported.