Status:
COMPLETED
Accuracy of Detection of Methemoglobin With Pulse Oximetry
Lead Sponsor:
Nonin Medical, Inc
Conditions:
Collect Blood Values With Induced Hypoxia, Induced Methemoglobinemia, and Induced Hypoxia and Methemoglobinemia
Eligibility:
All Genders
18-50 years
Brief Summary
The non-invasive measurement of dysfunctional hemoglobins allows physicians to monitor levels in affected individuals without requiring blood samples or laboratory testing. Nonin Medical Inc, has rece...
Detailed Description
The goal of this study is to collect data with induced hypoxia, with induced methemoglobinemia, and with induced hypoxia and methemoglobinemia. This will be accomplished in three runs with 24 to 28 pl...
Eligibility Criteria
Inclusion
- The subject is male or female.
- The subject is of any racial or ethnic group.
- The subject is between 18 years and 50 years of age (self-reported).
- The subject does not have significant medical problems (self-reported).
- The subject is willing to provide written informed consent and is willing and able to comply with study procedures.
Exclusion
- Has a BMI greater than 31 (calculated from self-reported weight and height).
- Has had any relevant injury at the sensor location site (self-reported).
- Has a deformity or abnormalities that may prevent proper application of the device under test (based on visual inspection).
- Has a known respiratory condition (self-reported).
- Is currently a smoker (self-reported).
- Has a known heart or cardiovascular condition (self-reported).
- Is currently pregnant (self-reported).
- Is female and actively trying to get pregnant (self-reported).
- Has a clotting disorder (self-reported).
- Has Raynaud's Disease (self-reported).
- Is known to have a hemoglobinopathy such as (anemia, bilirubinemia, sickle-cell anemia, inherited or congenital methemoglobinemia) (self-reported).
- The subject has a COHb greater than 3% or MetHb greater than 2% (based on the first blood sample analysis).
- Has taken blood thinners or medication with aspirin within the last 24 hours (self-reported).
- Has unacceptable collateral circulation from the ulnar artery (based on exam).
- Has donated more than 300 mL of blood within one month prior to start of study (self-reported).
- Is unwilling or unable to provide written informed consent to participate in the study.
- Is unwilling or unable to comply with the study procedures for the primary objectives.
- Has another health condition which in the opinion of the principal investigator makes him/her unsuitable for testing.
Key Trial Info
Start Date :
March 26 2019
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
March 29 2019
Estimated Enrollment :
13 Patients enrolled
Trial Details
Trial ID
NCT03869840
Start Date
March 26 2019
End Date
March 29 2019
Last Update
April 8 2019
Active Locations (1)
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1
University of California San Francisco
San Francisco, California, United States, 94118