SpO2 Validation of Noninvasive Red Diamond Disposable Pulse Oximeter Sensor
- Conditions
- Healthy
- Interventions
- Device: Red Diamond Disposable Pulse Oximeter Sensor
- Registration Number
- NCT03124602
- Lead Sponsor
- Masimo Corporation
- Brief Summary
In this study, the level of oxygen within the blood will be reduced in a controlled manner by reducing the concentration of oxygen the study volunteer breathes. The accuracy of a noninvasive pulse oximeter sensor will be assessed by comparison to the oxygen saturation measurements from a laboratory blood gas analyzer.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 35
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Test Subject Red Diamond Disposable Pulse Oximeter Sensor All subjects are enrolled into the test group and all subjects receive the noninvasive Red Diamond Disposable Pulse Oximeter Sensor
- Primary Outcome Measures
Name Time Method Accuracy of Red Diamond Disposable Pulse Oximeter Sensor by Arms Calculation 1-5 hours per subject Accuracy will be determined by comparing the noninvasive blood oxygen saturation measurement of the pulse oximeter to that obtained from a blood sample and calculating the Accuracy root mean square (ARMS) error value. In order to obtain the Arms value, the blood oxygen saturation measurement form a laboratory pulse Co-Oximeter is subtracted from the pulse oximeter oxygen saturation measurement for a number of samples, the average of this difference is computed as the bias. The standard deviation of the differences is computed as the precision. The square root of the sum of the squares of bias and precision is computed as the ARMS Error value.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Masimo Corporation
🇺🇸Irvine, California, United States