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Accuracy of Noninvasive Rainbow Adhesive R1 Pulse Oximeter Sensor

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.
ClinicalTrials.gov Identifier: NCT03134313
Recruitment Status : Completed
First Posted : April 28, 2017
Results First Posted : July 2, 2017
Last Update Posted : July 2, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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.

Condition or disease Intervention/treatment
Healthy Device: Rainbow Adhesive Noninvasive R1 Pulse Oximeter Sensor

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Actual Study Start Date : December 12, 2008
Primary Completion Date : June 19, 2009
Study Completion Date : June 19, 2009
Arms and Interventions

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


Outcome Measures

Primary Outcome Measures :
  1. Accuracy of SpHb on R1-25 by Arms Calculation [ Time Frame: 1-5 hours per subject ]
    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.


Eligibility Criteria

Information from the National Library of Medicine

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

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
Contacts and Locations

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): NCT03134313


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

Responsible Party: Masimo Corporation
ClinicalTrials.gov Identifier: NCT03134313     History of Changes
Other Study ID Numbers: TR18670-1029
First Posted: April 28, 2017    Key Record Dates
Results First Posted: July 2, 2017
Last Update Posted: July 2, 2017
Last Verified: June 2017

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