NCT03124966已完成不适用
Accuracy of Hemoglobin Measurement for Various Rainbow Pulse Oximeter Sensors
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 118
- 试验地点
- 2
- 主要终点
- Accuracy of Sensor 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 a noninvasive hemoglobin sensor(s) 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
- Na
- 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Study Site 1:
- •Inclusion Criteria:
- •Has physical status between ASA 1 or 2
- •Able to communicate in English
排除标准
- •Pregnant or sexually active without birth control.
- •Hemoglobin less than 11g/dL
- •Known alcohol or drug abuse
- •Skin abnormalities affecting the digits such as psoriasis, eczema, angioma, scar tissue, burn, fungal infection
- •Nail polish
- •Head injury with loss of consciousness within the last year
- •Known neurological and psychiatric conditions.
- •Known concurrent chronic usage of psychoactive or anti-convulsive drugs within the last 90 days, or use in the last 7 days (i.e. tricyclic antidepressants, MAO inhibitors, lithium, neuroleptics, anxiolytics or antipsychotics. Except SSRIs
- •Subject has any medical condition which, in the judgement of the investigator, renders them inappropriate for participation in this study, such as Raynaud's syndrome
- •Hypertension: Systolic BP >= 140 mmHg or Diastolic BP >= 90 mmHg
- •Baseline heart rate <50 beats per minute
- •Study Site 2:
- •Inclusion Criteria:
- •Male or female
- •18-35 years of age
- •Physical status of ASA I or II
- •Able to read and communicate in English
- •Has signed written informed consent
- •If female, non pregnant. If female subject is currently sexually active and not on birth control they must have a negative pregnancy test prior to study enrollment.
- •Exclusion Criteria
- •Age less than 18 yrs and greater than 35 years
- •Hemoglobin less than 12 g/dL
- •ASA physical status of III, IV, or V
- •Pregnant or sexually active without birth control
- •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, lithium, 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 Raynauds Syndrome.
- •Hypertension: Systolic BP >140 mmHg or Diastolic BP > 90 mmHg.
- •Baseline heart rate < 50 bpm.
- •Inability to tolerate sitting still or minimal movement for up to 90 minutes
研究组 & 干预措施
Noninvasive Hemoglobin Sensor
Experimental
All subjects are enrolled into the test group and all will receive the pulse oximeter sensor.
干预措施: Pulse Oximeter sensor (Device)
结局指标
主要结局
Accuracy of Sensor by Arms Calculation
时间窗: 1-3 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.
次要结局
未报告次要终点
研究者
研究点 (2)
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