NCT03157232

Rainbow DCI vs. R1-25 Sensor SpHb Sub-Range Performance Equivalence

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: Masimo Corporation · Industry
• Sex: All
• Age: 18 Years – 40 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy

Interventions

Type	Name	Description
DEVICE	Rainbow DCI and R1-25 sensor	Noninvasive Measurement of SpHb

Timeline

• Start date: 2009-06-19
• Primary completion: 2009-06-29
• Completion: 2009-06-29
• First posted: 2017-05-17
• Last updated: 2017-07-27
• Results posted: 2017-07-27

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study