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

Not Applicable

Completed

• Conditions: Healthy
• Interventions: Device: R1-25 and R2-25 Pulse Oximeter Sensor

• Registration Number: NCT03134326
• Lead Sponsor: Masimo Corporation

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-06-18
• Primary Completion: 2009-07-02
• Study Completion: 2009-07-02
• Study First Submitted: 2017-04-14
• Study First Submitted QC: 2017-04-27
• Study First Posted: 2017-04-28
• Results First Submitted: 2017-05-19
• Status Verified: 2017-06
• Results First Submitted QC: 2017-06-28
• Last Update Submitted: 2017-06-28
• Results First Posted: 2017-07-27
• Last Update Posted: 2017-07-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 21

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Test group	R1-25 and R2-25 Pulse Oximeter Sensor	All subjects will be enrolled in the test group and will receive both R1-25 and R2-25 Pulse Oximeter Sensors

Primary Outcome Measures

Name	Time	Method
Sub-Range Performance Equivalence of R2-25 and R1-25 Sensors by ARMS Calculation	1-5 hours	Sub-range performance equivalence was determined by comparing the noninvasive hemoglobin measurement of the pulse oximeter sensor to the hemoglobin value obtained from a blood sample and calculating the arithmetic root mean square (Arms) error value. In order to obtain the Arms value, the blood sample hemoglobin value is subtracted from the pulse oximeter hemoglobin value for a number of samples, the average of this difference is computed as the bias. The standard deviation of these differences is computed as the precision. The square root of the sum of the squares of bias and precision is computed as the Arms Error value.

Trial Locations

Locations (1)

Masimo Clinical Lab; 🇺🇸 Irvine, California, United States