Plethysmographic and Acoustic Respiration Rate Clinical Data Collection

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

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-12-31

Study Completion Date

2017-03-31

Brief Summary

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The objective of this clinical investigation is to collect high-resolution pulse oximetry, RRp, and RAM data in pediatric subjects for the purpose of algorithm optimization and to build a database of representative pulse oximetry and respiratory signal profiles for patients in this population.

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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

DEVICE_FEASIBILITY

Blinding Strategy

NONE

Study Groups

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Test Group

The subjects will be enrolled in the test group and will receive Pulse Oximeter with respiration rate sensor to examine the respiration rate.

Group Type EXPERIMENTAL

Pulse Oximeter with respiration rate sensor

Intervention Type DEVICE

Interventions

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Pulse Oximeter with respiration rate sensor

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Age: 0 to 5 years old
* Fully developed skin

Exclusion Criteria

* Subjects with skin abnormalities at the planned application sites that would interfere with sensor application.
* Subjects with pre-existing conditions and/or co-morbidities that would prohibit them from participating in the study due to unacceptable risks to their health and well-being, as determined by the Principal Investigator (PI).
* Subjects deemed not suitable for the study at the discretion of the investigator

Maximum Eligible Age

5 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes