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

Completed · Not applicable

Conditions studied: Healthy

In brief

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.

Key facts

Study ID

NCT03157232

Run by

Masimo Corporation

People needed

18

Starts

2009-06-19

Expected to finish

2009-06-29

Last updated by the study team

2017-07-27

Who can join

Age: 18 and older, up to 40. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Subjects must understand and consent to be in the study.
• American Society of Anesthesiology Class 1 (Healthy subjects without any systemic disease at all).

You may not qualify if…

• 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.

Where it is running

• Masimo — Irvine, California, United States

Full record on ClinicalTrials.gov

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