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

NCT ID: NCT03134326

Last Updated: 2017-07-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 21 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-06-18
• Study Completion Date: 2009-07-02

Brief 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.

Conditions

Healthy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER

Study Groups

Test group

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

Group Type: EXPERIMENTAL

R1-25 and R2-25 Pulse Oximeter Sensor

Intervention Type: DEVICE

Interventions

R1-25 and R2-25 Pulse Oximeter Sensor

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Masimo Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Masimo Clinical Lab

Irvine, California, United States

Countries

United States

Other Identifiers

TR18735-1029

Identifier Type: -

Identifier Source: org_study_id