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临床试验/NCT01732029
NCT01732029已完成不适用

Calibration and Evaluation of an Audio Pulse Oximeter Sensor (AudioOx) at Ascent and Descent From Simulated Altitude

University of British Columbia2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2013年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
20
试验地点
2
主要终点
Oxygen saturation

研究概览

简要总结

Pulse oximetry is a standard non-invasive method of measuring blood oxygen saturation (SpO2). In developing countries, pulse oximeters are rare because of expense and electricity requirements. Our ECEM group has developed the Phone Oximeter, which uses a cell phone (which are widely available in developing countries) to compute and analyze information from a pulse oximeter sensor. To further reduce costs, we have developed an oximeter sensor (AudioOx) that plugs into the audio jack of a standard cell phone. This study aims to calibrate the AudioOx by exposing 30 healthy adult volunteers to various altitudes in UBC's hypoxia chamber.

详细描述

Purpose:

We at the Electrical and Computer Engineering in Medicine Group (ECEM) at the University of British Columbia, Vancouver, Canada, plan to make pulse oximetry available to resource poor countries by designing a low-cost, battery-powered pulse oximeter device consisting of a low-cost pulse oximeter sensor connected to a cell phone. The use of cell phones as patient monitors is appealing as they are widely available in many developing countries. Utilizing battery power, cell phones do not rely on a continuous source of electricity. This is essential, as most low-resource settings lack adequate infrastructure and thus cannot provide the uninterrupted power supply required for conventional patient monitoring. Furthermore, a cell phone has the efficiency, integrated display, and processing power required to analyze and store the raw data derived from the pulse oximeter sensors. Data from the pulse oximeter can be transmitted to referral centers for diagnostic and advisory purposes where cellular and networking services permit.

Proprietary oximeter sensors and modules are expensive. To reduce cost, we are proposing to develop a simple audio pulse oximeter sensor (AudioOx) that that does not require a sensor module and interfaces via the audio jack of any standard cell phone. By utilizing the audio jack for transmission of data from the sensor to phone, we can ensure that cell phone types most common in various areas of the world are universally supported. Preliminary laboratory tests showed that oximetry data from the AudioOx has sufficient signal strength and resolution for extraction of heart rate and SpO2.

Hypothesis:

We hypothesize that this study will allow us to successfully calibrate the AudioOx.

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

  • Non-smokers
  • UBC students age 18 and older or non-university students age 19 and older
  • No medical history of respiratory, cardiovascular and neurological problems (capable of undergoing controlled hypoxemia down to SpO2 of 70%).

排除标准

  • Medical history including respiratory, cardiovascular and neurological problems
  • Smokers or individuals exposed to high levels of carbon monoxide that result in elevated carboxyhemoglobin levels (interferes with oximetry readings)

结局指标

主要结局

Oxygen saturation

时间窗: Across 3 hours

Accurately calibrated AudioOx for measuring oxygen saturation

次要结局

  • Heart rate(Across 3 hours)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mark Ansermino

Principle Investigator

University of British Columbia

研究点 (2)

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