Calibrate and Validate the wrist based noninvasive SpO2 measurement tracker to measure SpO2 during hand motion and hand at rest in comparison to “goldâ€standard†measurements of blood SaO2 by a CO †OXIMETER, hospital grade pulse oximeter and Over the counter pulse oximeter on healthy subjects
试验速览
- 阶段
- 不适用
- 状态
- 暂停
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- â—Calibrate and Validate the wrist based noninvasive SpO2 measurement tracker to measure SpO2 ranges (100-97, 97-92, 92-85, 84-78) during hand motion in in comparison to
研究概览
简要总结
Calibrate and Validate the wrist based noninvasive SpO2 measurement tracker to measure SpO2 during hand motion and hand at rest in comparison to “goldâ€standard†measurements of blood SaO2 by a CO †OXIMETER, hospital grade pulse oximeter and Over the counter pulse oximeter on healthy subjects.
| Total of 40 subjects |
The study will be performed on 30 subjects, the data collected from the 20 subjects will be used to calibrate and improve the algorithm accuracy of the wrist based tracker. Data collected from next 10 subjects will be used by sponsor for internal validation. 10 Days gap will be there to develop the algorithm and improve the final validation study.
10 new subjects will be enrolled for evaluating and documenting the accuracy of MUSE tracker and validation report will be prepared.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 50.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Male and female subjects having Age more than 18 -50 years with at least 1/3 darkly pigmentation 2.Subjects with BMI 18.5-30 3.Subjects wrist size for Female :5.5’to 6.5’ and Male :6.5-7.5’ 4.(Carboxyhemoglobin) Co value ≤2.0% FCOHb 5.Hemoglobin value is greater than or equal to 11g/dL 6.Baseline heart rate ≥45bpm and ≤85bpm.
- •7.Subject is willing to give written informed consent 8.Subject is willing and able to comply with all trial requirements 9.A negative pregnancy test result in women of childbearing potential.
排除标准
- •1.The subject is obese (BMI is greater than 30).
- •2.The subject has a known history of heart disease, lung disease, kidney or liver disease.
- •3.Diagnosis of asthma, sleep apnea, or use of CPAP.
- •4.Subject has diabetes.
- •5.Subject has a clotting disorder.
- •6.The subject a hemoglobinopathy or history of anemia.
结局指标
主要结局
â—Calibrate and Validate the wrist based noninvasive SpO2 measurement tracker to measure SpO2 ranges (100-97, 97-92, 92-85, 84-78) during hand motion in in comparison to
时间窗: SpO2 ranges (100-97, 97-92, 92-85, 84-78)- one time use
II.In comparison to hospital grade pulse oximeter
时间窗: SpO2 ranges (100-97, 97-92, 92-85, 84-78)- one time use
I.Goldâ€standard†measurements of blood SaO2 by a CO †OXIMETER
时间窗: SpO2 ranges (100-97, 97-92, 92-85, 84-78)- one time use
III.In comparison to Over the counter pulse oximeter
时间窗: SpO2 ranges (100-97, 97-92, 92-85, 84-78)- one time use
次要结局
- 1. Means for delivering medical-grade oxyg/en-nitrogen mixtures of varying fractional inspired oxygen (FiO2) levels.(2. To evaluate safety and performance of device)