Accuracy of Detection of Methemoglobin With Pulse Oximetry

NCT03869840 | Completed FDA Device

• 1 other identifier: QATP3186
• Study Type: observational
• Target: 13
• Locations: 1 country
• Sites: 1

Brief Summary

The non-invasive measurement of dysfunctional hemoglobins allows physicians to monitor levels in affected individuals without requiring blood samples or laboratory testing. Nonin Medical Inc, has recently developed a multi-wavelength device that measures carboxyhemoglobin and methemoglobin non-invasively. The primary objective of this study is to validate %MetHb and SpO2 accuracy performance of the study device. Evaluations will be for the range of 0 to 15% MetHb with 95-100% SaO2 as assessed by CO-oximetry, and 0-15% MetHb accuracy under conditions of elevated HHb (SaO2 80-100%) as assessed by CO-oximetry, and SpO2 with 80-100% SaO2 during elevated MetHb as assessed by CO-oximetry.

Conditions

Collect Blood Values With Induced Hypoxia, Induced Methemoglobinemia, and Induced Hypoxia and Methemoglobinemia

Outcome Measures

Primary Outcomes (1)

• Validate %MetHb

  Validate %MetHb accuracy over the range of 0-15% MetHb with SaO2 greater than 95% as assessed by CO-oximetry

  4 days

Secondary Outcomes (1)

• Validate the %MetHb accuracy

  4 days

Interventions

Sensor to spot check blood levels DEVICE

Sensor to check blood levels, not used as intervention

Eligibility Criteria

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

Study Population

A minimum of 12 subjects with a minimum of 200 data points for each primary and secondary objective will be enrolled in the study. The subject population will include both male and female subjects and will include a variety of skin tones.

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 31 (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 (self-reported).
• 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 a hemoglobinopathy such as (anemia, bilirubinemia, sickle-cell anemia, inherited or congenital methemoglobinemia) (self-reported).
• The subject has a COHb greater than 3% or MetHb greater than 2% (based on the first blood sample analysis).
• Has taken blood thinners or medication with aspirin within the last 24 hours (self-reported).
• Has unacceptable collateral circulation from the ulnar artery (based on exam).
• Has donated more than 300 mL of blood within one month prior to start of study (self-reported).

Sponsors & Collaborators

• Nonin Medical, Inc: lead

Study Sites (1)

University of California San Francisco

San Francisco, California, 94118, United States

Location

MeSH Terms

Conditions

Methemoglobinemia

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases

Study Design

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

Study Record Dates

• First Submitted: March 8, 2019
• First Posted: March 11, 2019
• Study Start: March 26, 2019
• Primary Completion: March 29, 2019
• Study Completion: March 29, 2019
• Last Updated: April 8, 2019

Record last verified: 2019-03

Locations

US (1)