N/A N=21 Other

Rainbow R2-25 vs. R1-25 SpHb Sub-Range Performance Equivalence

Healthy

Bottom Line

View on ClinicalTrials.gov: NCT03134326 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jul 2017

Primary outcome: Primary: Sub-Range Performance Equivalence of R2-25 and R1-25 Sensors by ARMS Calculation — 1.33; 1.41 g/dL

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: R1-25 and R2-25 Pulse Oximeter Sensor (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Masimo Corporation
Primary completion: Jul 2009

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	—

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.

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

View full record on ClinicalTrials.gov →

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.