N/A
Completed N=21
Rainbow R2-25 vs. R1-25 SpHb Sub-Range Performance Equivalence
Healthy
Source: ClinicalTrials.gov NCT03134326 ↗
Enrolled (actual)
21
Serious AEs
0.0%
Results posted
Jul 2017
Primary outcomePrimary: Sub-Range Performance Equivalence of R2-25 and R1-25 Sensors by ARMS Calculation — 1.33; 1.41 g/dL
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 12-17 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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Sub-Range Performance Equivalence of R2-25 and R1-25 Sensors by ARMS Calculation |
1.33; 1.41 | — |
Eligibility Criteria
Inclusion Criteria
- Greater than 18 years old
- Healthy
Exclusion criteria
- Do not understand the study and the risks involved
- Deemed ineligible by study test personnel
Data sourced from ClinicalTrials.gov (NCT03134326). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.