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临床试验/NCT05681637
NCT05681637Enrolling By Invitation不适用

SpO2 Difference Between Fingers of the Hand During Sequential Desaturation and Step Resaturation

Czech Technical University in Prague2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2023年1月31日最近更新:
适应症

试验速览

阶段
不适用
状态
Enrolling By Invitation
入组人数
40
试验地点
2
主要终点
Non-invasive SpO2 measurements will be performed continuously on all individual fingers of left hand of volunteers and then the measured values will be compared between each other.

研究概览

简要总结

The aim of the project is to experimentally compare the fingers of the hand in terms of measured concentrations of peripheral blood oxygen saturation (SpO2) in healthy humans during gradual desaturation in the range of 60-100% SpO2 and simultaneously during a step change from the hypoxic phase to the recovery phase (return to physiological values).

详细描述

The finger sensors of pulse oximeters are most often placed on the middle two fingers of the hand. Although there have been many studies looking at the accuracy of different pulse oximeters or comparing fingers in terms of SpO2. There is no study comparing fingers in terms of SpO2 under hypoxic condition with simultaneous randomization of finger probe placement. At the same time, there is no study that compares SpO2 changes between fingers during a step change in blood oxygen saturation. The data obtained could help to improve the reliability of monitoring physiological parameters with pulse oximeters.

研究设计

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

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Passing the initial examination, which will determine the following data: finger circumference, heart rate, blood pressure and blood oxygen saturation

排除标准

  • post-traumatic conditions of the upper limbs affecting the perfusion of the fingers or injuries or skin diseases on the fingers.
  • pneumothorax or a condition after cardiovascular surgery.
  • anemia, bradycardia, hemoglobinopathy or other diseases of the cardiovascular system, pregnancy, diabetes, hypotension or hypertension.

结局指标

主要结局

Non-invasive SpO2 measurements will be performed continuously on all individual fingers of left hand of volunteers and then the measured values will be compared between each other.

时间窗: 1 hour

The experiment can help determine if it depends on which finger the finger sensor will be placed to measure SpO2. Appropriate finger selection for SpO2 measurements could help to better interpret the measured values and possibly increase the success in diagnosing health events.

次要结局

  • Non-invasive Perfusion Index measurements will be performed continuously on all individual fingers of left hand of volunteers and then the measured values will be compared between each other.(1 hour)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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