Dysfunctional Hemoglobin

Completed

• Conditions: Elevated Levels of Carboxyhemoglobin and Methemoglobin
• Interventions: Other: Elevated levels of carboxyhemoglobin

• Registration Number: NCT02262195
• Lead Sponsor: Nonin Medical, Inc

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2014-10
• Study Start: 2014-10
• Study First Submitted: 2014-10-07
• Study First Submitted QC: 2014-10-07
• Study First Posted: 2014-10-10
• Primary Completion: 2015-03
• Study Completion: 2015-03
• Last Update Submitted: 2015-04-20
• Last Update Posted: 2015-04-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 62

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Carboxyhemoglobin	Elevated levels of carboxyhemoglobin	Induced carboxyhemoglobin levels up tp 15 percent.
Methemoglobin	Elevated levels of carboxyhemoglobin	Induced methemoglobin levels up to 15 percent.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Determine oxygen saturation accuracy in conditions of elevated methemoglobin	4 hours
Determine oxygen saturation accuracy in conditions of elevated carboxyhemoglobin	4 hours

Trial Locations

Locations (1)

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