Accuracy of Noninvasive Rainbow Adhesive R1 Pulse Oximeter Sensor

In this study, the concentration of hemoglobin will be measured using a noninvasive pulse oximeter sensor and compared with the hemoglobin value from a blood sample of the volunteer. The accuracy of a noninvasive hemoglobin sensor(s) will be assessed by comparison to hemoglobin measurements from a laboratory analyzer.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Device: Rainbow Adhesive Noninvasive R1 Pulse Oximeter Sensor

• Study Type: Interventional
• Enrollment (Actual): 25
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Irvine, California, United States, 92618
      • Masimo Clinical Lab

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: R1-25 Sensor; All subjects will be enrolled in the test group and will receive Rainbow Adhesive Noninvasive R1 Pulse Oximeter Sensor	Device: Rainbow Adhesive Noninvasive R1 Pulse Oximeter Sensor

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Accuracy of SpHb on R1-25 by Arms Calculation	Accuracy will be determined by comparing the noninvasive hemoglobin measurement of the pulse oximeter 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 the 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 per subject

Collaborators and Investigators

• Sponsor: Masimo Corporation

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 12, 2008
• Primary Completion (ACTUAL): June 19, 2009
• Study Completion (ACTUAL): June 19, 2009

Study Registration Dates

• First Submitted: April 14, 2017
• First Submitted That Met QC Criteria: April 27, 2017
• First Posted (ACTUAL): April 28, 2017

Study Record Updates

• Last Update Posted (ACTUAL): July 2, 2017
• Last Update Submitted That Met QC Criteria: June 28, 2017
• Last Verified: June 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: TR18670-1029

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes