Accuracy of Methemoglobin Measurement for Rainbow DCI Sensors
Not Applicable
Completed
- Conditions
- Healthy
- Interventions
- Device: DCI pulse oximeter sensor
- Registration Number
- NCT03124927
- Lead Sponsor
- Masimo Corporation
- Brief Summary
In this study, the level of methemoglobin (HbMet) will be increased in a controlled manner by administering sodium nitrite intravenously in healthy volunteers. The accuracy of a noninvasive HbMet measurement by a DCI pulse oximeter sensor will be assessed by comparison to blood measurements from a laboratory analyzer.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 25
Inclusion Criteria
- Subjects must understand and consent to be in the study
- American Society of Anesthesiology Class I (Healthy subjects without any systemic disease at all).
Exclusion Criteria
- Subjects who have any systemic disease at all.
- Subjects who do not understand the study and the risks involved.
- Current smokers.
- Subjects who are pregnant.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Test Group DCI pulse oximeter sensor All subjects are enrolled into the test group and all subjects receive DCI pulse oximeter sensor.
- Primary Outcome Measures
Name Time Method Accuracy of Sensor by Arms Calculation 5 hours Accuracy will be determined by comparing the noninvasive blood methemoglobin measurement of the pulse oximeter to that obtained from a blood sample and calculating the arithmetic root mean square (Arms) error value.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (2)
University of California, San Francisco
🇺🇸San Francisco, California, United States
University of Arizona
🇺🇸Tucson, Arizona, United States