Rainbow DCI vs. R1-25 Sensor SpHb Sub-Range Performance Equivalence
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Masimo Corporation
- Enrollment
- 18
- Locations
- 2
- Primary Endpoint
- Sub-Range Performance Equivalence of Rainbow DCI and R1-25 Sensors by ARMS Calculation
Study Overview
Brief Summary
In this study, the concentration of hemoglobin was measured using noninvasive pulse oximeter sensors and compared against the hemoglobin measurement from the subject's blood sample under controlled conditions. Data collected in the study was in the sub-range of 11-17 g/dL in the device's 8-17 g/dL specification range.
The purpose of the study was to evaluate a change in the sensor component and to assess performance equivalence in the sub-range. The performance of non-invasive hemoglobin is not uniform across the accuracy range.
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 1 (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.
- •Subjects who are pregnant.
- •Subjects having either signs or history or peripheral ischemia. Others deemed ineligible by the clinical staff.
Outcomes
Primary Outcomes
Sub-Range Performance Equivalence of Rainbow DCI and R1-25 Sensors by ARMS Calculation
Time Frame: 1-5 hours per subject
Sub-range performance equivalence was determined by comparing the noninvasive hemoglobin measurement of the pulse oximeter sensor to the hemoglobin value obtained from a blood sample and calculating the arithmetic root mean square (Arms) error value.In order to obtain the Arms value, the blood sample hemoglobin value is subtracted from the pulse oximeter hemoglobin value for a number of samples, the average of this difference is computed as the bias. The standard deviation of these 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 Outcomes
No secondary outcomes reported