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

Masimo

Status: Completed

Conditions: Healthy

Treatments: Device: R1-25 and R2-25 Pulse Oximeter Sensor

Study type: Interventional

Funder types: Industry

Identifiers

NCT03134326

TR18735-1029

Details and patient eligibility

About

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.

Enrollment: 21 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

21 participants in 1 patient group

Test group

Experimental group

Description:

All subjects will be enrolled in the test group and will receive both R1-25 and R2-25 Pulse Oximeter Sensors

Treatment:

Device: R1-25 and R2-25 Pulse Oximeter Sensor