Accuracy of Detection of Methemoglobin With Pulse Oximetry

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.

Study Overview

• Status: Completed
• Conditions: Collect Blood Values With Induced Hypoxia, Induced Methemoglobinemia, and Induced Hypoxia and Methemoglobinemia
• Intervention / Treatment: Device: Sensor to spot check blood levels

Detailed Description

The goal of this study is to collect data with induced hypoxia, with induced methemoglobinemia, and with induced hypoxia and methemoglobinemia. This will be accomplished in three runs with 24 to 28 plateaus total. The number of plateaus will be dependent on the subject's tolerance of the study procedure. The first run will be strictly induction of hypoxia down to approximately 70% saturation. The second run will be induction of hypoxia down to approximately 80% saturation with mild hypoxia at 7% MetHb. The third run will be induction of hypoxia down to approximately 80% saturation with a target MetHb of 11-15%.

• Study Type: Observational
• Enrollment (Actual): 13

Contacts and Locations

Study Locations

• United States
  • California
    • San Francisco, California, United States, 94118
      • University of California San Francisco

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• 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.

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 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).
• Is unwilling or unable to provide written informed consent to participate in the study.
• Is unwilling or unable to comply with the study procedures for the primary objectives.
• 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?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Validate the %MetHb accuracy	Validate the %MetHb accuracy with SaO2 greater than 80% as assessed by CO-oximetry An accuracy value (Arms) for %SpO2 over the range of 80-100% SaO2 with elevated MetHb levels.	4 days

Collaborators and Investigators

• Sponsor: Nonin Medical, Inc

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 26, 2019
• Primary Completion (ACTUAL): March 29, 2019
• Study Completion (ACTUAL): March 29, 2019

Study Registration Dates

• First Submitted: March 8, 2019
• First Submitted That Met QC Criteria: March 8, 2019
• First Posted (ACTUAL): March 11, 2019

Study Record Updates

• Last Update Posted (ACTUAL): April 8, 2019
• Last Update Submitted That Met QC Criteria: April 4, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Hematologic Diseases; Signs and Symptoms, Respiratory; Hypoxia; Methemoglobinemia
• Other Study ID Numbers: QATP3186

Drug and device information, study documents

• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes