Dysfunctional Hemoglobin CO-ox

Completed

• Conditions: Elevated Levels of Carboxyhemoglobin

• Registration Number: NCT02427685
• Lead Sponsor: Nonin Medical, Inc

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2015-04
• Study Start: 2015-04
• Study First Submitted: 2015-04-20
• Study First Submitted QC: 2015-04-27
• Study First Posted: 2015-04-28
• Primary Completion: 2015-05
• Study Completion: 2015-05
• Last Update Submitted: 2015-06-16
• Last Update Posted: 2015-06-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 27

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Carboxyhemoglobin over the range of 0-15 percent as assessed by co-oximetry.	3 hours

Secondary Outcome Measures

Name	Time	Method
Oxygen saturation accuracy in conditions of elevated carboxyhemoglobin.	3 hours

Trial Locations

Locations (1)

University of California San Francisco; 🇺🇸 San Francisco, California, United States