Dysfunctional Hemoglobin

Nonin Medical

Status

Completed

Conditions

Elevated Levels of Carboxyhemoglobin and Methemoglobin

Treatments

Other: Elevated levels of carboxyhemoglobin

Study type

Observational

Funder types

Other

Industry

Identifiers

NCT02262195

QATP2338

Details and patient eligibility

About

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

Enrollment

62 patients

Sex

All

Ages

18 to 45 years old

Volunteers

Accepts Healthy Volunteers

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