NCT02262195CompletedNot Applicable
Dysfunctional Hemoglobin Pulse Co-ox
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Nonin Medical, Inc
- Enrollment
- 62
- Locations
- 1
- Primary Endpoint
- Evaluate carboxyhemoglobin over the range of 0-15 percent as assessed by co-oximetry
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to 45 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •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 Criteria
- •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
Outcomes
Primary Outcomes
Evaluate carboxyhemoglobin over the range of 0-15 percent as assessed by co-oximetry
Time Frame: 4 hours
Evaluate methemoglobin over the range of 0-15 percent as assessed by co-oximetry
Time Frame: 4 hours
Secondary Outcomes
- Determine oxygen saturation accuracy in conditions of elevated methemoglobin(4 hours)
- Determine oxygen saturation accuracy in conditions of elevated carboxyhemoglobin(4 hours)
Investigators
Study Sites (1)
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