Dysfunctional Hemoglobin CO-ox

Dysfunctional Hemoglobin

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

Study Overview

• Status: Completed
• Conditions: Elevated Levels of Carboxyhemoglobin
• Intervention / Treatment: Device: Pulse Co-Ox

• Study Type: Observational
• Enrollment (Actual): 27

Contacts and Locations

Study Locations

• United States
  • California
    • San Francisco, California, United States, 94118
      • University of California San Francisco

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Healthy adult volunteers

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Carboxyhemoglobin over the range of 0-15 percent as assessed by co-oximetry.	3 hours

Secondary Outcome Measures

Outcome Measure	Time Frame
Oxygen saturation accuracy in conditions of elevated carboxyhemoglobin.	3 hours

Collaborators and Investigators

• Sponsor: Nonin Medical, Inc
• Investigators: Principal Investigator: Phillip E Bickler, MD, PhD, University of California, San Francisco

Study record dates

Study Major Dates

• Study Start: April 1, 2015
• Primary Completion (Actual): May 1, 2015
• Study Completion (Actual): May 1, 2015

Study Registration Dates

• First Submitted: April 20, 2015
• First Submitted That Met QC Criteria: April 27, 2015
• First Posted (Estimate): April 28, 2015

Study Record Updates

• Last Update Posted (Estimate): June 17, 2015
• Last Update Submitted That Met QC Criteria: June 16, 2015
• Last Verified: April 1, 2015

More Information

Terms related to this study

• Other Study ID Numbers: QATP2687