Dysfunctional Hemoglobin Pulse Oximetry

Dysfunctional Hemoglobin Pulse Oximeter

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

Study Overview

• Status: Completed
• Conditions: Carbon Monoxide Poisoning
• Intervention / Treatment: Device: Pulse Oximeter

• Study Type: Observational
• Enrollment (Actual): 36

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • HPPL Duke Univeristy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 48 years (Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Healthy male and females.

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 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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Carboxyhemoglobin accuracy	Values from the test device will be compared to the values from co-oximetry to determine accuracy of the test device.	Through study completion, an average of 3 months.

Collaborators and Investigators

• Sponsor: Nonin Medical, Inc
• Investigators: Principal Investigator: David B MacLeod, MD, Duke University

Study record dates

Study Major Dates

• Study Start (Actual): February 6, 2017
• Primary Completion (Actual): April 30, 2017
• Study Completion (Actual): April 30, 2017

Study Registration Dates

• First Submitted: January 23, 2017
• First Submitted That Met QC Criteria: January 23, 2017
• First Posted (Estimate): January 25, 2017

Study Record Updates

• Last Update Posted (Actual): September 1, 2017
• Last Update Submitted That Met QC Criteria: August 31, 2017
• Last Verified: January 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Chemically-Induced Disorders; Gas Poisoning; Poisoning; Carbon Monoxide Poisoning
• Other Study ID Numbers: QATP3040

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes