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临床试验/NCT03328039
NCT03328039已完成不适用

uSing Wearable TEchnology to Predict Perioperative High-riSk Patient Outcomes

Cardiff University1 个研究点 分布在 1 个国家目标入组 47 人开始时间: 2017年2月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
47
试验地点
1
主要终点
Successful recoding of accelerometer data

研究概览

简要总结

This is an observational, non-interventional study to assess the equivalence of wearable monitors with formal CPET testing for the prediction of physiological reserve before major surgery.

详细描述

This project will exploit the rapid development of wearable technology to allow perioperative risk prediction to become logistically easier, cost effective and used more broadly. It will use low cost wearable technology to complement or act as a surrogate to complex CPET testing performed for perioperative risk stratification. The data gained from a Garmin Vivosmart HR+ wearable device, will be used in the community by patients awaiting surgery, and will be correlated with key CPET indices including anaerobic threshold and peak VO2. Ultimately, this study aims to assess whether wearable technology can provide the data needed for the formation of prediction models to risk assess perioperative outcomes in patients undergoing high-risk elective surgery. In addition, an International Physical Activity Questionnaire (IPAQ) will be completed to compare the activity captured with self-reported activity. This will be combined with frailty scores and handgrip strength as is routinely collected during CPET. Finally, a saliva based genetic analysis will be conducted on genetic variations known to be of significance in critical illness and response to physical stress. This will be delivered by a laboratory (Fitness Genes) that has developed a bespoke panel of genetic markers ideally suited to this patient cohort.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Aged 18 years or older with capacity to consent
  • Clinical indications for planned CPET testing before planned major elective surgery

排除标准

  • Atrial fibrillation
  • Nickel allergy
  • Unable to wear a watch
  • Unable to conduct CPET
  • Pregnancy

结局指标

主要结局

Successful recoding of accelerometer data

时间窗: 7 days

Successful recoding of accelerometer data

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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