Accuracy of SpO2 for Noninvasive Pulse Oximeter Sensor (LNCS ADTX)

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

13 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-09-30

Study Completion Date

2014-10-09

Brief Summary

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In this study, the level of oxygen within the blood will be reduced in a controlled manner by reducing the concentration 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.

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Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Test Subject

All subjects are enrolled into the test group and receive the LNCS ADTX Sensor.

Group Type EXPERIMENTAL

LNCS ADTX Sensor

Intervention Type DEVICE

Noninvasive pulse oximeter sensor.

Interventions

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LNCS ADTX Sensor

Noninvasive pulse oximeter sensor.

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes