Dysfunctional Hemoglobin Pulse Oximetry

Carbon Monoxide Poisoning Clinical Trial

Official title:

Dysfunctional Hemoglobin Pulse Oximeter

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03030833
• Other study ID #: QATP3040
• Status: Completed
• Phase: N/A
• First received: January 23, 2017
• Last updated: August 31, 2017
• Start date: February 6, 2017
• Est. completion date: April 30, 2017

Study information

• Verified date: January 2017
• Source: Nonin Medical, Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: April 30, 2017
• Est. primary completion date: April 30, 2017
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Carbon Monoxide Poisoning
• Poisoning

Intervention

Device:
• Pulse Oximeter
Comparison of pulse oximetry to blood gas analyzer.

Locations

Country	Name	City	State
United States	HPPL Duke Univeristy	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Nonin Medical, Inc

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.