NCT03124927CompletedNot Applicable
Accuracy of Methemoglobin Measurement for Rainbow DCI Sensors
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Masimo Corporation
- Enrollment
- 25
- Locations
- 4
- Primary Endpoint
- Accuracy of Sensor by Arms Calculation
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 40 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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.
Outcomes
Primary Outcomes
Accuracy of Sensor by Arms Calculation
Time Frame: 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 Outcomes
No secondary outcomes reported
Investigators
Study Sites (4)
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