Dysfunctional Hemoglobin

Dysfunctional Hemoglobin Pulse Co-ox

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

Study Overview

• Status: Completed
• Conditions: Elevated Levels of Carboxyhemoglobin and Methemoglobin
• Intervention / Treatment: Other: Elevated levels of carboxyhemoglobin

• Study Type: Observational
• Enrollment (Actual): 62

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: 16 years to 43 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Healthy Adult volunteers

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Carboxyhemoglobin; Induced carboxyhemoglobin levels up tp 15 percent.	Other: Elevated levels of carboxyhemoglobin; Comparison of pulse co-oximeters; Other Names: Elevated levels of methemoglobin
Methemoglobin; Induced methemoglobin levels up to 15 percent.	Other: Elevated levels of carboxyhemoglobin; Comparison of pulse co-oximeters; Other Names: Elevated levels of methemoglobin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Evaluate carboxyhemoglobin over the range of 0-15 percent as assessed by co-oximetry	4 hours
Evaluate methemoglobin over the range of 0-15 percent as assessed by co-oximetry	4 hours

Secondary Outcome Measures

Outcome Measure	Time Frame
Determine oxygen saturation accuracy in conditions of elevated carboxyhemoglobin	4 hours
Determine oxygen saturation accuracy in conditions of elevated methemoglobin	4 hours

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start: October 1, 2014
• Primary Completion (Actual): March 1, 2015
• Study Completion (Actual): March 1, 2015

Study Registration Dates

• First Submitted: October 7, 2014
• First Submitted That Met QC Criteria: October 7, 2014
• First Posted (Estimate): October 10, 2014

Study Record Updates

• Last Update Posted (Estimate): April 21, 2015
• Last Update Submitted That Met QC Criteria: April 20, 2015
• Last Verified: October 1, 2014

More Information

Terms related to this study

• Other Study ID Numbers: QATP2338