Accuracy of Noninvasive Pulse Oximeter Sensor (LNCS DBI)

Masimo

Status: Completed

Conditions: Healthy

Treatments: Device: LNCS DBI Sensor

Study type: Interventional

Funder types: Industry

Identifiers

NCT03124979

TR22194-TP16113

Details and patient eligibility

About

In this study, the level of oxygen within the blood will be reduced in a controlled manner by reducing the percentage of oxygen the study volunteer breathes. The accuracy of a noninvasive pulse oximeter sensor will be assessed by comparison to the oxygen saturation measurements from a laboratory blood gas analyzer.

Enrollment: 13 patients

Sex: All

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Competent non-smoking adults between the ages of 18 and 40 for each series of tests.
• Subjects must understand and consent to be in the study.
• American Society of Anesthesiology Class 1 (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.
• Smokers.
• Subjects who are pregnant.
• Subjects having either signs or history of peripheral ischemia.
• Others deemed ineligible by the clinical staff.

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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13 participants in 1 patient group

Test Subject

Other group

Description:

All subjects are enrolled into the test group and all subjects received the LNCS DBI Sensor.

Treatment:

Device: LNCS DBI Sensor