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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.
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%.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sensor to spot check blood levels | Device | Sensor to check blood levels, not used as intervention |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California San Francisco | San Francisco | California | 94118 | United States |
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| ID | Term |
|---|---|
| D008708 | Methemoglobinemia |
| ID | Term |
|---|---|
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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