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

NCT03134326 | Completed Results FDA Device

• 1 other identifier: TR18735-1029
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Sub-Range Performance Equivalence of R2-25 and R1-25 Sensors by ARMS Calculation

  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.

  1-5 hours

Study Arms (1)

Test group

EXPERIMENTAL

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

Device: R1-25 and R2-25 Pulse Oximeter Sensor

Interventions

R1-25 and R2-25 Pulse Oximeter Sensor DEVICE

Test group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Greater than 18 years old
• Healthy

You may not qualify if:

• Do not understand the study and the risks involved
• Deemed ineligible by study test personnel

Sponsors & Collaborators

• Masimo Corporation: lead

Study Sites (1)

Masimo Clinical Lab

Irvine, California, 92618, United States

Location

Results Point of Contact

• Title: Vikram Ramakanth
• Organization: Masimo

clinicalresearchdept@masimo.com

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 14, 2017
• First Posted: April 28, 2017
• Study Start: June 18, 2009
• Primary Completion: July 2, 2009
• Study Completion: July 2, 2009
• Last Updated: July 27, 2017
• Results First Posted: July 27, 2017

Record last verified: 2017-06

Locations

US (1)