NCT02427685已完成不适用
Dysfunctional Hemoglobin
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 27
- 试验地点
- 1
- 主要终点
- Carboxyhemoglobin over the range of 0-15 percent as assessed by co-oximetry.
研究概览
简要总结
The study verifies accuracy of a new pulse co-oximeter in the presence of elevated carboxyhemoglobin levels.
研究设计
- 研究类型
- Observational
- 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
- •The subject is male or female.
- •The subject is of any racial or ethnic group.
- •The subject is between 18 years and 45 years of age.
- •The subject does not have significant medical problems.
- •The subject is willing to provide written informed consent and is willing and able to comply with study procedures.
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.
- •Has Raynaud's Disease.
- •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 for the primary objectives.
- •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
Carboxyhemoglobin over the range of 0-15 percent as assessed by co-oximetry.
时间窗: 3 hours
次要结局
- Oxygen saturation accuracy in conditions of elevated carboxyhemoglobin.(3 hours)
研究者
研究点 (1)
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