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Accuracy of Detection of Methemoglobin With Pulse Oximetry

NCT03869840 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 13

Last updated 2019-04-08

No results posted yet for this study

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

Interventions

DEVICE

Sensor to spot check blood levels

Sensor to check blood levels, not used as intervention

Sponsors & Collaborators

  • Nonin Medical, Inc

    lead INDUSTRY

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-03-26
Primary Completion
2019-03-29
Completion
2019-03-29
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03869840 on ClinicalTrials.gov