Comparison of Noninvasive Hemoglobin Disposable Sensors
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 44
- 试验地点
- 2
- 主要终点
- Accuracy of Noninvasive Sensors by Arms Calculation
研究概览
简要总结
In this study, the concentration of hemoglobin within the subject's blood will be reduced in a controlled manner by administering fluids intravenously. The accuracy of two noninvasive hemoglobin sensors will be assessed by comparison to hemoglobin measurements from a laboratory analyzer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female
- •18-40 years of age
- •Weight of at least 110 lbs and less than 250 lbs for subjects under 6 feet tall.
- •Physical status of ASA I of II
- •Able to read and communicate in English
- •Has signed written informed consent
- •Female, non pregnant.
排除标准
- •Age less than 18 yrs and greater than 40 years
- •If the Warming and cooling subjects have open cuts of skin abrasions on their extremities they will be excluded because alcohol spray may be painful.
- •Weight of less than 110 lbs or more than 250 lbs if the subject is less than 6 feet tall.
- •Hemoglobin less than 11 g/dL
- •ASA physical status of III. IV, V.
- •Subject has known drug or alcohol abuse
- •Subject has skin abnormalities affecting the digits such as psoriasis, eczema, angioma, scar tissue, burn, fungal infection, substantial skin breakdown, nail polish or acrylic nails.
- •Subject has experienced a head injury with loss of consciousness within the last year.
- •Subject has known neurological and psychiatric disorder that interferes with the subjects' level of consciousness.
- •Known or concurrent chronic usage of psychoactive or anticonvulsive drugs within the last 90 days, or any use in the last 7 day (i.e. tricyclic antidepressants, MAO inhibitors, Lithum, neuroleptics, anxiolytics or antipsychotics, except SSRIs).
- •Subject has any medical condition which in the judgment of the investigator, renders them inappropriate for participation in this study, such as Reynauds Syndrome.
- •Systolic BP >140 mmHg or Diastolic BP > 100 mmHg.
- •Baseline heart rate < 50 bpm.
- •Inability to tolerate sitting still or minimal movement for up to 90 minutes
- •Discretion of investigator
研究组 & 干预措施
Group- Sensor 1
All subjects are enrolled into the test group and receive the Rainbow adhesive adult/pediatric sensors.
干预措施: Rainbow adhesive adult/pediatric sensor (Device)
Group- Sensor 2
All subjects are enrolled into the test group and receive the Rainbow adhesive adult/neonatal sensors.
干预措施: Rainbow adhesive adult/neonatal sensor (Device)
结局指标
主要结局
Accuracy of Noninvasive Sensors by Arms Calculation
时间窗: 1-5 hours
Accuracy will be determined by comparing the noninvasive hemoglobin measurement of the pulse oximeter to the hemoglobin value obtained from a blood sample and calculating the arithmetic root mean square (Arms) error value. The accuracy results from both sensors will be assessed for equivalence
次要结局
未报告次要终点