Accuracy of Noninvasive Pulse Oximeter Sensor (MightySat RX)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-11-12

Study Completion Date

2014-12-17

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 all subjects receive the MightySat RX Pulse Oximeter Sensor.

Group Type EXPERIMENTAL

MightySat RX Pulse Oximeter Sensor

Intervention Type DEVICE

Noninvasive pulse oximeter finger sensor.

Interventions

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MightySat RX Pulse Oximeter Sensor

Noninvasive pulse oximeter finger sensor.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* 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