Point-of-Care End-Tidal Carbon Monoxide Measurement to Screen for Sickle Cell Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 32
- 主要终点
- End-Tidal Carbon Monoxide
研究概览
简要总结
Modify the design of the CoSense device (Model C20112, currently cleared by the FDA for ETCO (end-tidal carbon monoxide) monitoring to improve accuracy and consistency under temperature conditions encountered in countries with high prevalence of SCD (Sickle Cell Disease).
详细描述
Increase the temperature operating range of ETCO measurements to 5 to 45°C. The signal output-to-CO (carbon monoxide) concentration correlation of the CO sensor is dependent on temperature. The new algorithm will be a different approach because the current algorithm is at the limits of its capability. We will establish the new specifications by determining performance in a bench model under simulated temperature conditions. We will then determine the ability of the modified device to distinguish between SCD and healthy controls. During this initial testing, we will examine the validity of ETCO measurements under regulated room temperature in the hospital setting. We will enroll 20 subjects, 10 each in the SCD arm and control arm to determine the mean and variance of the ETCO values.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 1 Year 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Parental / legal guardian consent
- •Subject assent for participants ages 7 and above
- •Male and female children ages 1-18 years old
- •For Hb SS (Homozygous sickle cell anemia) subjects, hemoglobin baseline hemoglobin ≤10 g/dL based upon average hemoglobin value in past year
排除标准
- •Subjects must not meet any of the following exclusion criteria to be considered eligible for study enrollment:
- •Had a red blood cell transfusion within 8 weeks prior to enrollment
- •Currently a primary smoker or was a primary smoker within 4 weeks prior to enrollment
- •Exposed to second hand smoke within 24 hours prior to breath sample collections
- •Have current upper respiratory infection or symptomatic asthma
- •For healthy subjects, known to have the sickle cell trait by electrophoresis or genetic testing
结局指标
主要结局
End-Tidal Carbon Monoxide
时间窗: 1 hour
Compare ETCO between subjects and controls
次要结局
未报告次要终点