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Rainbow DCI vs. R1-25 Sensor SpHb Sub-Range Performance Equivalence

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ClinicalTrials.gov Identifier: NCT03157232
Recruitment Status : Completed
First Posted : May 17, 2017
Results First Posted : July 27, 2017
Last Update Posted : July 27, 2017
Sponsor:
Information provided by (Responsible Party):
Masimo Corporation

Study Description
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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 11-17 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: Rainbow DCI and R1-25 sensor Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Actual Study Start Date : June 19, 2009
Actual Primary Completion Date : June 29, 2009
Actual Study Completion Date : June 29, 2009
Arms and Interventions
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Arm Intervention/treatment
Experimental: Test Group
All subjects are enrolled into the test group and all subjects received both the Rainbow DCI and R1-25 sensor.
 Device: Rainbow DCI and R1-25 sensor
Noninvasive Measurement of SpHb


Outcome Measures
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Primary Outcome Measures :
  1. Sub-Range Performance Equivalence of Rainbow DCI and R1-25 Sensors by ARMS Calculation [ Time Frame: 1-5 hours per subject ]
    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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Subjects must understand and consent to be in the study.
  • American Society of Anesthesiology Class 1 (Healthy subjects without any systemic disease at all).

Exclusion Criteria:

  • Subjects who have any systemic disease at all.
  • Subjects who do not understand the study and the risks.
  • Smokers.
  • Subjects who are pregnant.
  • Subjects having either signs or history or peripheral ischemia. Others deemed ineligible by the clinical staff.
Contacts and Locations
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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 ClinicalTrials.gov identifier (NCT number): NCT03157232


Locations
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United States, California
Masimo
Irvine, California, United States, 92618
Sponsors and Collaborators
Masimo Corporation
More Information
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Responsible Party: Masimo Corporation
ClinicalTrials.gov Identifier: NCT03157232    
Other Study ID Numbers: TR18695-TP14480
First Posted: May 17, 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
Product Manufactured in and Exported from the U.S.: No