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

Masimo

Status: Completed

Conditions: Healthy

Treatments: Device: Rainbow DCI and R1-25 sensor

Study type: Interventional

Funder types: Industry

Identifiers

NCT03157232

TR18695-TP14480

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 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.

Enrollment: 18 patients

Sex: All

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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18 participants in 1 patient group

Test Group

Experimental group

Description:

All subjects are enrolled into the test group and all subjects received both the Rainbow DCI and R1-25 sensor.

Treatment:

Device: Rainbow DCI and R1-25 sensor