跳至主要内容
临床试验/NCT05943730
NCT05943730招募中不适用

The Validity of a Seismocardiography Device to Estimate Peak Oxygen Uptake in Patients Awaiting Major Elective Surgery

Northumbria University3 个研究点 分布在 1 个国家目标入组 143 人开始时间: 2023年8月31日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
143
试验地点
3
主要终点
Phase 1 outcome - refine algorithm

研究概览

简要总结

Physical fitness levels of people waiting for a planned operation are often measured using an exercise test. This is because fitness levels help doctors make a plan to improve each person's chances of a successful recovery after their planned operation. The exercise test requires skilled staff, expensive equipment, a 1 hour appointment, and the patient to exercise heavily during the test.

Ventriject, a small to medium sized enterprise, have designed a device called Seismofit that estimates fitness levels of people from a measurement taken whilst laying down. It measures the vibrations of the chest wall caused by the beating heart and uses this information with additional information, such as height, weight and sex, to estimate fitness. The measurement takes around 5 minutes to perform, does not require heavy exercise, expensive equipment or skilled staff.

The Seismofit device was shown to be accurate in young fairly fit people. It has not been tested in people who undergo an exercise test before an operation, who are less fit on average compared to the people that the device was originally tested on. It is likely that the calculations used to estimate fitness levels with the Seismofit device will need to be adjusted for people waiting for an operation. There are two parts to this study. The first part aims to estimate up to 50 people's fitness with the Seismofit device and use directly measured fitness from their standard exercise test before their operation to adjust the calculations for estimating fitness. The second part of this study aims to have a further 50 people undergo the Seismofit device measurement and compare the estimated fitness level with the results from the standard exercise test before an operation. This is to see if the Seismofit device is valid at estimating fitness in people awaiting surgery.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
盲法
None

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

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

Seismofit Validity

Experimental

Participants will undergo a seismocardiography assessment, whilst supine, using the seismofit device. This will estimate their peak oxygen consumption. Participants will then undergo a maximal cardiopulmonary exercise test (CPET), where peak oxygen consumption will be measured. The Seismofit estimated peak oxygen consumption will be compared with CPET measured peak oxygen consumption (unless prespecified criteria for a maximal exercise test are not met).

干预措施: Seismofit (Device)

结局指标

主要结局

Phase 1 outcome - refine algorithm

时间窗: Up to 6 months

Up to 50 patients awaiting major surgery will have their estimated V̇O2peak (ml/kg/min) recorded using the Seismofit device and actual V̇O2peak (ml/kg/min) measured in their standard preoperative cardiopulmonary exercise test. The Seismofit algorithm will be adjusted using these data points with machine learning.

Phase 2 outcome - validity of refined algorithm

时间窗: 12 months

The correlation between the new seismofit algorithm estimate of V̇O2peak (ml/kg/min) and CPET measured and verified V̇O2peak (ml/kg/min) in up to 50 preoperative patients that have valid tests in accordance with maximal exercise test criteria stated in the protocol (RER \> 1.10 or maximum heart rate attained within 10 beats of predicted maximum).

次要结局

  • Bland-Altman analysis(12 months)
  • Existing V̇O2peak predicted equation analysis(12 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (3)

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