A Multi-Center Study on the Utility of Non-invasive Carboxyhemoglobin and Total Hemoglobin Measurement in Emergency Department Patients
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 813
- 试验地点
- 2
- 主要终点
- SpCO Detection of Carbon Monoxide Poisoning (COP)
研究概览
简要总结
The purpose of this study is to determine the clinical utility of triage screening for anemia and carbon monoxide poisoning (COP) in the ED setting.This is a prospective, nonrandomized, multi-center study of the performance of simultaneous non-invasive testing for two common disorders (COP and anemia). We will determine the limits of agreement and performance characteristics of non-invasive carboxyhemoglobin (SpCO) and hemoglobin (SpHb) values compared to standard blood tests for measurement of carboxyhemoglobin and hemoglobin, in the emergency department setting.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 1 Year 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 1 year or older.
- •At least one digit has acceptable width as measured by study-provided digit gauge.
- •Presenting to emergency department for any complaint.
- •Potential for IV catheter and/or blood draw for CBC as standard of care.
排除标准
- •Patients unable to consent for any reason
- •Patients with fingernail polish, discoloration or trauma to fingers
结局指标
主要结局
SpCO Detection of Carbon Monoxide Poisoning (COP)
时间窗: up to 3 hours
Diagnostics performance of SpCO for detecting COP measured by sensitivity and specificity compared to COHb.
Utility of SpCO as a Screening Tool for Carbon Monoxide Poisoning
时间窗: up to 3 hours
Surveying healthcare providers whether SpCO screening lead to identification of occult toxicity
SpHb Utility for Screening Anemia
时间窗: up to 3 hours
Establish SpHb threshold that predicts the clinical outcome for acute treatment of anemia
Specificity of SpHb in Detecting Anemia.
时间窗: up to 3 hours
Specificity in detecting true non-anemic subjects as determined by co-oximeter reference analyzer.
Carbon Monoxide (CO) Elimination Pharmacokinetics in Relation to Oxygen Administration
时间窗: up to 3 hours
CO elimination will be evaluated as a function of administered oxygen.
Difference Between SpCO and COHb
时间窗: Up to 3 hours
Measure the difference between noninvasive carboxyhemoglobin (SpCO) and carboxyhemoglobin determined by co-oximeter measurement of blood (COHb) as calculated in terms of standard deviation. The average difference between paired Masimo noninvasive carboxyhemoglobin (SpCO) and reference carboxyhemoglobin (COHb) determined by co-oximeter measurement of blood represented as mean bias.
Sensitivity of SpHb Detection of Anemia.
时间窗: up to 3 hours
Sensitivity in detecting true anemic subjects as determined by co-oximeter reference analyzer.
次要结局
未报告次要终点