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临床试验/NCT06626217
NCT06626217尚未招募不适用

Comparison of Perfusion Index Monitoring Using a Smartwatch and a Pulse Oximeter

Czech Technical University in Prague0 个研究点目标入组 50 人开始时间: 2024年10月8日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
50
主要终点
Comparison of measured perfusion index values between pulse oximeter and smartwatch during different interventions.

研究概览

简要总结

The aim of the study is to experimentally compare measured perfusion index values between smartwatch and a medical grade pulse oximeter in healthy subjects at rest and with and without motion artifacts and during exercise.

详细描述

Perfusion index (PI) is one of the many vital signs monitored to assess the clinical status of a patient. PI is determined from the pulsatile part of the plethysmographic curve, with typical values measured on the fingers ranging from 0.02% to 20%. Although PI is a relatively newly measured parameter, it has already found application in many areas of clinical medicine. For example, continuous measurement of the perfusion index has been used to monitor changes in finger blood flow after finger replantation (surgical reattachment of the finger to the patient's body). As the ability to monitor the perfusion index begins to become part of the monitored parameters of smartwatches, this new feature could be used in situations where the use of finger sensors is not appropriate. However, no comparison of perfusion index measurements between smartwatch and pulse oximeter has been made to date.

研究设计

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

入排标准

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

入选标准

  • Healthy Adult Volunteer

排除标准

  • Post-traumatic upper limb conditions affecting finger or arm perfusion
  • Injuries or diseases of the skin of the fingers and arm
  • Any acute phase of any disease

结局指标

主要结局

Comparison of measured perfusion index values between pulse oximeter and smartwatch during different interventions.

时间窗: 1 hour

The comparison of measured perfusion index values between pulse oximeter and smartwatch during different interventions (Resting conditions, Movement artifacts, Circulation costriction and Physical exercise) will be analyzed.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

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