Collect Blood Values With Induced Hypoxia, Induced Methemoglobinemia, and Induced Hypoxia and Methemoglobinemia Clinical Trial
Official title:
Accuracy of Detection of Methemoglobin With Pulse Oximetry
| NCT number | NCT03869840 |
| Other study ID # | QATP3186 |
| Secondary ID | |
| Status | Completed |
| Phase | |
| First received | |
| Last updated | |
| Start date | March 26, 2019 |
| Est. completion date | March 29, 2019 |
| Verified date | March 2019 |
| Source | Nonin Medical, Inc |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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.
| Status | Completed |
| Enrollment | 13 |
| Est. completion date | March 29, 2019 |
| Est. primary completion date | March 29, 2019 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| 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 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. |
| Country | Name | City | State |
|---|---|---|---|
| United States | University of California San Francisco | San Francisco | California |
| Lead Sponsor | Collaborator |
|---|---|
| Nonin Medical, Inc |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | 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 |