ECHONOF III trial - participants with isolated, primary and non metastatic NOF
收藏figshare.unimelb.edu.au2024-08-01 更新2025-03-25 收录
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The ECHONOF III trial aims to recruit patients presenting with isolated, primary, non-metastatic
fractured neck of femur, where surgery is expected within 48 hours after hospital admission. Depend on randomisation outcome, 50% of the trial participants will receive trial intervention. The intervention is not a stand-alone product per se, but rather an ultrasound examination of the heart. In addition to clinical
evaluation, participants randomised to the focused cardiac ultrasound group will receive a preoperative focused cardiac ultrasound performed prior to surgery, following The University of Melbourne iHeartScan protocol. The control group will consist of current standard of care practice which does not involve routine
use of preoperative focused cardiac ultrasound.
The study dataset may also include a set of QoL surveys, such as PostopQRS survey, clinical frailty scale, ED-5D-5L and Lawton Brody IADL scale.
Please note that the study dataset may only be available once the ECHONOF III trial is completed and concluded. Assessing and utilising the ECHONOF III dataset for research purposes may require additional ethical approval.
ECHONOF III临床试验旨在招募那些出现孤立性、原发性、非转移性股骨颈骨折的患者,预计在接受医院治疗后48小时内进行手术。根据随机分配结果,试验参与者中的50%将接受试验干预。该干预本身并非独立产品,而是一种心脏超声检查。除了临床评估外,随机分配至聚焦心脏超声组的参与者将在手术前根据墨尔本大学iHeartScan方案接受术前聚焦心脏超声检查。对照组将包括当前标准护理实践,该实践不涉及常规使用术前聚焦心脏超声。研究数据集还可能包括一系列生活质量调查问卷,如术后QRS调查、临床衰弱量表、ED-5D-5L和生活能力量表(Lawton Brody IADL scale)。请注意,只有在ECHONOF III临床试验完成并得出结论后,研究数据集才可能可用。评估和利用ECHONOF III数据集进行科研目的可能需要额外的伦理审批。
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