N/A
Completed N=18
Rainbow DCI vs. R1-25 Sensor SpHb Sub-Range Performance Equivalence
Healthy
Source: ClinicalTrials.gov NCT03157232 ↗
Enrolled (actual)
18
Serious AEs
0.0%
Results posted
Jul 2017
Primary outcomePrimary: Sub-Range Performance Equivalence of Rainbow DCI and R1-25 Sensors by ARMS Calculation — 1.2; 1.2 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 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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Sub-Range Performance Equivalence of Rainbow DCI and R1-25 Sensors by ARMS Calculation |
1.2; 1.2 | — |
Eligibility Criteria
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.
- Smokers.
- Subjects who are pregnant.
- Subjects having either signs or history or peripheral ischemia. Others deemed ineligible by the clinical staff.
Data sourced from ClinicalTrials.gov (NCT03157232). 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.