Accuracy of Noninvasive Hemoglobin Measurement (SpHb) Using Rainbow DCI Pulse Oximeter Sensor
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 3
- 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 is affected by fluid status changes. The fluid status is affected by fluid loss during surgery for hospitalized study subjects or controlled administration of fluids intravenously for healthy study volunteers. The accuracy of a noninvasive hemoglobin sensor(s) will be assessed by comparing with blood sample analysis.
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
- •Healthy Volunteers
- •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 Reynauds syndrome
- •Hypertension: Systolic BP >= 140 mmHg or Diastolic BP >= 90 mmHg
- •Baseline heart rate <50 beats per minute
- •Surgical Subjects
- •Inclusion Criteria:
- •Age > 18 years old
- •Scheduled for surgery requiring frequent schedule blood draws as a part of their routine care
- •Exclusion Criteria:
- •Pregnant or lactating women
- •Skin abnormalities at the planed application sites that would interfere with transilluminating the finger, or other measurement sites, like burns, scar tissue, nail polish, infections etc.
研究组 & 干预措施
Test Group
All subjects are enrolled into the test group and all subjects received the Rainbow DCI pulse oximeter sensor.
干预措施: Rainbow DCI pulse oximeter sensor (Device)
结局指标
主要结局
Accuracy of Sensor by Arms Calculation
时间窗: Up to 24 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