Dysfunctional Hemoglobin Pulse Oximetry

Completed

• Conditions: Carbon Monoxide Poisoning

• Registration Number: NCT03030833
• Lead Sponsor: Nonin Medical, Inc

Brief Summary

The purpose of the study is to assess device performance in the presence of carbon monoxide.

Detailed Description

Not available

Study Timeline

• Status Verified: 2017-01
• Study First Submitted: 2017-01-23
• Study First Submitted QC: 2017-01-23
• Study First Posted: 2017-01-25
• Study Start: 2017-02-06
• Primary Completion: 2017-04-30
• Study Completion: 2017-04-30
• Last Update Submitted: 2017-08-31
• Last Update Posted: 2017-09-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

• The subject is male or female.
• The subject is of any racial or ethnic group.
• The subject is between 18 years and 50 years of age (self-reported).
• The subject does not have significant medical problems (self-reported).
• 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 30.0 (calculated from self-reported weight and height).
• Has had any relevant injury at the sensor location site (self-reported).
• Has a deformity or abnormalities that may prevent proper application of the device under test (based on visual inspection).
• Has a known respiratory condition (self-reported).
• Is currently a smoker (self-reported).
• Has a known heart or cardiovascular condition (self-reported).
• Is currently pregnant (positive serum pregnancy test at screening visit or positive urine POC test on day of study).
• Is female and actively trying to get pregnant (self-reported).
• Has a clotting disorder (self-reported).
• Has Raynaud's Disease (self-reported).
• Is known to have anemia (hemoglobin value below lower range of normal for gender)
• Is known to have a hemoglobinopathy such as sickle-cell anemia or thalassemia (abnormal hemoglobin electrophoresis).
• Is known to have a inherited or congenital methemoglobinemia (self-reported).
• Has unacceptable collateral circulation from the ulnar artery (based on exam).
• Is unwilling or unable to provide written informed consent to participate in the study.
• 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 accuracy	Through study completion, an average of 3 months.	Values from the test device will be compared to the values from co-oximetry to determine accuracy of the test device.

Trial Locations

Locations (1)

HPPL Duke Univeristy; 🇺🇸 Durham, North Carolina, United States