NCT03869840

Accuracy of Detection of Methemoglobin With Pulse Oximetry

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 13 (actual)
• Sponsor: Nonin Medical, Inc · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

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.

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%.

Conditions

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

Interventions

Type	Name	Description
DEVICE	Sensor to spot check blood levels	Sensor to check blood levels, not used as intervention

Timeline

• Start date: 2019-03-26
• Primary completion: 2019-03-29
• Completion: 2019-03-29
• First posted: 2019-03-11
• Last updated: 2019-04-08

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study