Status:
COMPLETED
Dysfunctional Hemoglobin
Lead Sponsor:
Nonin Medical, Inc
Collaborating Sponsors:
University of California, San Francisco
Conditions:
Elevated Levels of Carboxyhemoglobin and Methemoglobin
Eligibility:
All Genders
18-45 years
Brief Summary
The purpose of the study is to determine if a new pulse oximeter accurately detects carboxyhemoglobin and methemoglobin when intentionally increased in the blood.
Eligibility Criteria
Inclusion
- Subjects does not have significant medical problems
- Subject is willing to provide written informed consent
- Subject is between 18 and 45 years of age
Exclusion
- Has a BMI greater than 31
- Has had any relevant injury at the sensor location site
- Has deformities or abnormalities that may prevent proper application of the device under test
- Has a known respiratory condition
- Is currently a smoker
- Has a known heart or cardiovascular condition
- Is currently pregnant
- Is female and actively trying to get pregnant
- Has a clotting disorder
- Is known to have a hemoglobinopathy such as (anemia, bilirubinemia, sickle-cell anemia, inherited or congenital methemoglobinemia)
- The subject has a COHb greater than 3% or MetHb greater than 2%
- Has taken blood thinners or medication with aspirin within the last 24 hours
- Has unacceptable collateral circulation from the ulnar artery
- Has donated more than 300 mL of blood within one month prior to start of study
- Is unwilling or unable to provide written informed consent to participate in the study
- Is unwilling or unable to comply with the study procedures
- Has another health condition which in the opinion of the principal investigator makes him/her unsuitable for testing
Key Trial Info
Start Date :
October 1 2014
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
March 1 2015
Estimated Enrollment :
62 Patients enrolled
Trial Details
Trial ID
NCT02262195
Start Date
October 1 2014
End Date
March 1 2015
Last Update
April 21 2015
Active Locations (1)
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1
University of California San Francisco
San Francisco, California, United States, 94118