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Accuracy of Methemoglobin Measurement for Rainbow DCI Sensors

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ClinicalTrials.gov Identifier: NCT03124927
Recruitment Status : Completed
First Posted : April 24, 2017
Results First Posted : June 12, 2017
Last Update Posted : June 12, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
In this study, the level of methemoglobin (HbMet) will be increased in a controlled manner by administering sodium nitrite intravenously in healthy volunteers. The accuracy of a noninvasive HbMet measurement by a DCI pulse oximeter sensor will be assessed by comparison to blood measurements from a laboratory analyzer.

Condition or disease Intervention/treatment
Healthy Device: DCI 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 : April 23, 2008
Primary Completion Date : August 8, 2008
Study Completion Date : August 8, 2008
Arms and Interventions

Arm Intervention/treatment
Experimental: Test Group
All subjects are enrolled into the test group and all subjects receive DCI pulse oximeter sensor.
Device: DCI pulse oximeter sensor


Outcome Measures

Primary Outcome Measures :
  1. Accuracy of Sensor by Arms Calculation [ Time Frame: 5 hours ]
    Accuracy will be determined by comparing the noninvasive blood methemoglobin measurement of the pulse oximeter to that obtained from a blood sample and calculating the arithmetic root mean square (Arms) error value.


Eligibility Criteria

Information from the National Library of Medicine

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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:

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

Exclusion Criteria:

  1. Subjects who have any systemic disease at all.
  2. Subjects who do not understand the study and the risks involved.
  3. Current smokers.
  4. Subjects who are pregnant.
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): NCT03124927


Locations
United States, Arizona
University of Arizona
Tucson, Arizona, United States, 85724
United States, California
University of California, San Francisco
San Francisco, California, United States, 94143
Sponsors and Collaborators
Masimo Corporation
More Information

Responsible Party: Masimo Corporation
ClinicalTrials.gov Identifier: NCT03124927     History of Changes
Other Study ID Numbers: TR-17413-REDF0003
First Posted: April 24, 2017    Key Record Dates
Results First Posted: June 12, 2017
Last Update Posted: June 12, 2017
Last Verified: May 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
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No