Accuracy of Methemoglobin Measurement for Rainbow DCI Sensors

In this study, the level of methemoglobin (HbMet) will be increased in a controlled manner by administering sodium nitrite intravenously in healthy volunteers. The accuracy of a noninvasive HbMet measurement by a DCI pulse oximeter sensor will be assessed by comparison to blood measurements from a laboratory analyzer.

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Key information

Conditions

Healthy

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Arizona, Tucson, Arizona, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Subjects must understand and consent to be in the study
American Society of Anesthesiology Class I (Healthy subjects without any systemic disease at all).

Exclusion criteria

Subjects who have any systemic disease at all.
Subjects who do not understand the study and the risks involved.
Current smokers.
Subjects who are pregnant.

Treatment and study plan

DCI pulse oximeter sensor

Device

Primary outcomes

Accuracy of Sensor by Arms Calculation

Time frame: 5 hours

Accuracy will be determined by comparing the noninvasive blood methemoglobin measurement of the pulse oximeter to that obtained from a blood sample and calculating the arithmetic root mean square (Arms) error value.

Sponsors and collaborators

Lead sponsor

Masimo Corporation

Industry

Registry information

Important dates

Study start: 2008
Primary completion: 2008
Study completion: 2008
First posted: Apr 24, 2017
Registry last updated: Jun 12, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed