Expired Study
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San Francisco, California 94118


Purpose:

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


Criteria:

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.


NCT ID:

NCT02427685


Primary Contact:

Principal Investigator
Phillip E Bickler, MD, PhD
University of California, San Francisco


Backup Contact:

N/A


Location Contact:

San Francisco, California 94118
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: November 18, 2019

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