Accuracy of Methemoglobin Measurement for Rainbow DCI Sensors

Masimo

Status: Completed

Conditions: Healthy

Treatments: Device: DCI pulse oximeter sensor

Study type: Interventional

Funder types: Industry

Identifiers

NCT03124927

TR-17413-REDF0003

Details and patient eligibility

About

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.

Enrollment: 25 patients

Sex: All

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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25 participants in 1 patient group

Test Group

Experimental group

Description:

All subjects are enrolled into the test group and all subjects receive DCI pulse oximeter sensor.

Treatment:

Device: DCI pulse oximeter sensor