Dysfunctional Hemoglobin Pulse Oximetry

NCT03030833 | Completed FDA Device

• 1 other identifier: QATP3040
• Study Type: observational
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Carbon Monoxide Poisoning

Outcome Measures

Primary Outcomes (1)

• 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.

Interventions

Pulse Oximeter DEVICE

Comparison of pulse oximetry to blood gas analyzer.

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Healthy male and females.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nonin Medical, Inc: lead

Study Sites (1)

HPPL Duke Univeristy

Durham, North Carolina, 27710, United States

Location

MeSH Terms

Conditions

Carbon Monoxide Poisoning

Condition Hierarchy (Ancestors)

Gas Poisoning; Poisoning; Chemically-Induced Disorders

Study Officials

• David B MacLeod, MD

  Duke University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 23, 2017
• First Posted: January 25, 2017
• Study Start: February 6, 2017
• Primary Completion: April 30, 2017
• Study Completion: April 30, 2017
• Last Updated: September 1, 2017

Record last verified: 2017-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)