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Accuracy of Methemoglobin Measurement of Various Rainbow Pulse Oximeter Sensors

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: NCT03124836
Recruitment Status : Completed
First Posted : April 24, 2017
Results First Posted : July 27, 2017
Last Update Posted : July 27, 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 the noninvasive HbMet measurement by a Pulse Oximeter Sensor will be assessed by comparison to blood measurements from a laboratory analyzer.

Condition or disease Intervention/treatment
Healthy Device: Pulse Oximeter Sensor

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 28 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Actual Study Start Date : November 18, 2009
Primary Completion Date : December 17, 2009
Study Completion Date : December 17, 2009
Arms and Interventions

Arm Intervention/treatment
Experimental: R2-25 Sensor
All subjects will be enrolled in the test group and will receive R2-25 Pulse Oximeter Sensor
Device: Pulse Oximeter Sensor


Outcome Measures

Primary Outcome Measures :
  1. Accuracy of Methemoglobin Measurement by Arms Calculation [ Time Frame: 1-5 hours ]
    Accuracy willl be determined by comparing the noninvasive blood methemoglobin measurement (expressed as a percentage of total hemoglobin) of the pulse oximeter to that 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 methemoglobin value is subtracted from the pulse oximeter methemoglobin 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 to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. The subject is male or female, aged ≥18 and <50.
  2. The subject is in good general health with no evidence of any medical problems.
  3. The subject is fluent in both written and spoken English.
  4. The subject has provided informed consent and is willing to comply with the study procedures.

Exclusion Criteria:

  1. The subject is obese (BMI>30).
  2. The subject has a known history of heart disease, lung disease, kidney or liver disease.
  3. Diagnosis of asthma, sleep apnea, or use of CPAP.
  4. Subject has diabetes.
  5. Subject has a clotting disorder.
  6. The subject has a hemoglobinopathy or history of anemia, per subject report or the first blood sample, that in the opinion of the investigator, would make them unsuitable for study participation.
  7. The subject has any other serious systemic illness.
  8. The subject is a current smoker.
  9. Any injury, deformity, or abnormality at the sensor sites that in the opinion of the investigators' would interfere with the sensors working correctly.
  10. The subject has a history of fainting or vasovagal response.
  11. The subject has a history of sensitivity to local anesthesia or allergy to the study drugs.
  12. The subject has a diagnosis of Raynaud's disease.
  13. The subject has unacceptable collateral circulation based on exam by the investigator (Allen's test).
  14. The subject is pregnant, lactating or trying to get pregnant.
  15. The subject has a history of migraine headaches.
  16. Th subject is currently taking antidepressants.
  17. The subject is unable or unwilling to provide informed consent, or is unable or unwilling to comply with study procedures.
  18. The subject has any other condition, which in the opinion of the investigators' would make them unsuitable for the study.
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): NCT03124836


Locations
United States, California
University of San Francisco
San Francisco, California, United States, 94117
Sponsors and Collaborators
Masimo Corporation
More Information

Responsible Party: Masimo Corporation
ClinicalTrials.gov Identifier: NCT03124836     History of Changes
Other Study ID Numbers: TR19427-BICK0001
First Posted: April 24, 2017    Key Record Dates
Results First Posted: July 27, 2017
Last Update Posted: July 27, 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