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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03134326
Recruitment Status : Completed
First Posted : April 28, 2017
Results First Posted : July 27, 2017
Last Update Posted : July 27, 2017
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Healthy Device: R1-25 and R2-25 Pulse Oximeter Sensor Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 21 participants
Intervention Model: Single Group Assignment
Primary Purpose: Other
Actual Study Start Date : June 18, 2009
Actual Primary Completion Date : July 2, 2009
Actual Study Completion Date : July 2, 2009

Arm Intervention/treatment
Experimental: Test group
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

Primary Outcome Measures :
  1. Sub-Range Performance Equivalence of R2-25 and R1-25 Sensors by ARMS Calculation [ Time Frame: 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03134326

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United States, California
Masimo Clinical Lab
Irvine, California, United States, 92618
Sponsors and Collaborators
Masimo Corporation

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Responsible Party: Masimo Corporation Identifier: NCT03134326     History of Changes
Other Study ID Numbers: TR18735-1029
First Posted: April 28, 2017    Key Record Dates
Results First Posted: July 27, 2017
Last Update Posted: July 27, 2017
Last Verified: June 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No