NCT03124901已完成不适用
Accuracy of Noninvasive Pulse Oximeter Measurement of Hemoglobin for Rainbow DCI Sensor
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 147
- 试验地点
- 4
- 主要终点
- Accuracy of Sensor
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
- •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 Reynods syndrome
- •Hypertension: Systolic BP >= 140 mmHg or Diastolic BP >= 90 mmHg
- •Baseline heart rate <50 beats per minute
结局指标
主要结局
Accuracy of Sensor
时间窗: Up to 24 hours
Accuracy willl 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 (4)
Loading locations...
相似试验
已完成
不适用
Accuracy of Noninvasive Hemoglobin Measurement (SpHb) Using Rainbow DCI Pulse Oximeter SensorHealthySurgeryNCT03124693Masimo Corporation90
已完成
不适用
Accuracy of Noninvasive Hemoglobin Pulse Oximeter (Rainbow Resposable Adhesive Sensors)HealthyNCT03124771Masimo Corporation132
已完成
不适用
Validation of Noninvasive Hemoglobin, Comparison of PVI to Standard Methods, and Validation of Clinical Efficacy of ORISurgeryNCT02841397Masimo Corporation50
已完成
不适用
Influence of Oxygen on Non-invasive Measurement of HemoglobinAnesthesiaNCT01654913Hopital Foch47
已完成
不适用
Accuracy of blood haemoglobin levels measured non-invasively, in patients undergoing prostate resection surgeryCTRI/2019/02/017528one50