Dysfunctional Hemoglobin CO-ox

Nonin Medical

Status: Completed

Conditions: Elevated Levels of Carboxyhemoglobin

Treatments: Device: Pulse Co-Ox

Study type: Observational

Funder types: Industry

Identifiers

NCT02427685

QATP2687

Details and patient eligibility

About

The study verifies accuracy of a new pulse co-oximeter in the presence of elevated carboxyhemoglobin levels.

Enrollment: 27 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• The subject is male or female.
• The subject is of any racial or ethnic group.
• The subject is between 18 years and 45 years of age.
• The subject does not have significant medical problems.
• The subject is willing to provide written informed consent and is willing and able to comply with study procedures.

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.
• Has Raynaud's Disease.
• 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 for the primary objectives.
• Has another health condition which in the opinion of the principal investigator makes him/her unsuitable for testing.