NCT02262195已完成不适用
Dysfunctional Hemoglobin Pulse Co-ox
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 62
- 试验地点
- 1
- 主要终点
- Evaluate carboxyhemoglobin over the range of 0-15 percent as assessed by co-oximetry
研究概览
简要总结
The purpose of the study is to determine if a new pulse oximeter accurately detects carboxyhemoglobin and methemoglobin when intentionally increased in the blood.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects does not have significant medical problems
- •Subject is willing to provide written informed consent
- •Subject is between 18 and 45 years of age
排除标准
- •Has a BMI greater than 31
- •Has had any relevant injury at the sensor location site
- •Has deformities or abnormalities that may prevent proper application of the device under test
- •Has a known respiratory condition
- •Is currently a smoker
- •Has a known heart or cardiovascular condition
- •Is currently pregnant
- •Is female and actively trying to get pregnant
- •Has a clotting disorder
- •Is known to have a hemoglobinopathy such as (anemia, bilirubinemia, sickle-cell anemia, inherited or congenital methemoglobinemia)
- •The subject has a COHb greater than 3% or MetHb greater than 2%
- •Has taken blood thinners or medication with aspirin within the last 24 hours
- •Has unacceptable collateral circulation from the ulnar artery
- •Has donated more than 300 mL of blood within one month prior to start of study
- •Is unwilling or unable to provide written informed consent to participate in the study
- •Is unwilling or unable to comply with the study procedures
- •Has another health condition which in the opinion of the principal investigator makes him/her unsuitable for testing
结局指标
主要结局
Evaluate carboxyhemoglobin over the range of 0-15 percent as assessed by co-oximetry
时间窗: 4 hours
Evaluate methemoglobin over the range of 0-15 percent as assessed by co-oximetry
时间窗: 4 hours
次要结局
- Determine oxygen saturation accuracy in conditions of elevated methemoglobin(4 hours)
- Determine oxygen saturation accuracy in conditions of elevated carboxyhemoglobin(4 hours)
研究者
研究点 (1)
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