Dysfunctional Hemoglobin

Completed

Conditions studied: Elevated Levels of Carboxyhemoglobin and Methemoglobin

In brief

The purpose of the study is to determine if a new pulse oximeter accurately detects carboxyhemoglobin and methemoglobin when intentionally increased in the blood.

Key facts

Study ID

NCT02262195

Run by

Nonin Medical, Inc

People needed

62

Starts

2014-10-01

Expected to finish

2015-03-01

Last updated by the study team

2015-04-21

Who can join

Age: 18 and older, up to 45. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Subjects does not have significant medical problems
• Subject is willing to provide written informed consent
• Subject is between 18 and 45 years of age

You may not qualify if…

• 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

Where it is running

• University of California San Francisco — San Francisco, California, United States

Full record on ClinicalTrials.gov

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