Calibration and Validation of High Quality Low-Cost 3D Printed Pulse Oximeter
试验速览
- 阶段
- 不适用
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Arterial blood gas
研究概览
简要总结
Pulse oximetry is a vital tool in the rapid and non-invasive assessment of emergency patients, providing a continuous estimate of hemoglobin saturation in arterial blood. Unfortunately, the costs of these devices are prohibitive and reduce availability in smaller centres and poor countries, putting millions of patients in danger of easily treatable and preventable conditions. With current rapid prototyping technologies such as 3D printing, it is possible to create a very inexpensive pulse oximeter that meets or exceeds the gold standard. The goal of this study is to develop, validate and certify a pulse oximeter that measures hemoglobin, carboxyhemoglobin and methemoglobin. This pulse oximeter will be certified with Health Canada, and then released under the Open Hardware License (OHL), such that hospitals and ministries of health in rural and impoverished communities in Canada and internationally would have easy access to these devices.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •This study has 2 Phases. In Phase 1, healthy, non-smoking adult volunteers greater than 18 years of age are invited to participate. In Phase 2, all adult (>18) non-critical patients and healthy community volunteers visiting the ED at VH and UH are eligible to participate.
排除标准
- •Potential participants will be excluded based on the following criteria:
- •greater than 70 years of age,
- •current smokers,
- •previous history of cardiac disease (e.g., atrial fibrillation, myocardial infarction, congestive heart failure),
- •history of moderate or severe asthma,
- •history of seizures,
- •history of stroke or transient ischemic attack
- •pregnant women
- •Patients with any active pulmonary disease such as pneumonia
- •Individuals who are unwilling to participate or are less than 18 years old
- •Those who are unable to consent
- •Critical patients will be excluded from participating
- •Individuals who are unwilling to participate or are less than 18 years old will be excluded
- •Those who are unable to consent.
结局指标
主要结局
Arterial blood gas
时间窗: 1 hour
Arterial blood gases will be taken to create a proper calibration curve along with the device's readings.
Pulse oximetry reading
时间窗: 1 hour
Pulse oximetry readings will be taken over the span of an hour to calibrate the device
次要结局
未报告次要终点
研究者
Tarek Loubani, MD
Principal Investigator
Lawson Health Research Institute