跳至主要内容
临床试验/NCT06635018
NCT06635018已完成不适用

Effect of Pulse Oximeter Device on Measured Perfusion Index Values

Czech Technical University in Prague1 个研究点 分布在 1 个国家目标入组 42 人开始时间: 2024年2月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
42
试验地点
1
主要终点
Comparison of Perfusion Index Values Measured by Pulse Oximeters From Different Manufacturers During Rest, Movement, and Circulatory Restriction

研究概览

简要总结

The aim of this study is to experimentally determine the effect of pulse oximeters from different manufacturers on measured perfusion index values in healthy subjects at rest and with and without motion artifacts.

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. It can be used as an indicator of the severity of health status in different groups of critically ill patients, e.g. in patients with sepsis, in patients after cardiac arrest, for early detection of critical heart defects, for indirect assessment of patient pain, as an indicator of fluid therapy and reactivity, or for assessment and evaluation of anaesthesia in the operating room. However, there is currently no standardised calculation of PI and different manufacturers use different algorithms for the calculation. The consequence is that absolute measured values cannot be compared between devices.

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 perfusion
  • Injuries or diseases of the skin of the fingers
  • Any acute phase of any disease

研究组 & 干预措施

Determination of effect of pulse oximeters from different manufacturers on measured Perfusion index

Experimental

Three finger pulse oximeter sensors from different manufacturers are placed on the middle fingers of one hand. Three interventions subsequently follow (Resting condition, Movement artifacts and Circulation constriction).

干预措施: Resting conditions (Other)

Determination of effect of pulse oximeters from different manufacturers on measured Perfusion index

Experimental

Three finger pulse oximeter sensors from different manufacturers are placed on the middle fingers of one hand. Three interventions subsequently follow (Resting condition, Movement artifacts and Circulation constriction).

干预措施: Movement artifacts (Other)

Determination of effect of pulse oximeters from different manufacturers on measured Perfusion index

Experimental

Three finger pulse oximeter sensors from different manufacturers are placed on the middle fingers of one hand. Three interventions subsequently follow (Resting condition, Movement artifacts and Circulation constriction).

干预措施: Circulation constriction (Other)

结局指标

主要结局

Comparison of Perfusion Index Values Measured by Pulse Oximeters From Different Manufacturers During Rest, Movement, and Circulatory Restriction

时间窗: 1 hour

Perfusion index values will be measured and compared using pulse oximeters from different manufacturers under various conditions, including resting state, movement artifacts, and circulatory restriction. This evaluation will provide a direct comparison of the variability in perfusion index measurements across devices under each condition.

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)

Loading locations...

相似试验