Plethysmographic and Acoustic Respiration Rate Clinical Data Collection

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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Key information

Conditions

Healthy

Age range

Up to 5 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Medical Office of Mohammad T. Bailony

National City, California, 91950, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pulse Oximeter with respiration rate sensor

Device

Primary outcomes

Collection of high-resolution pulse oximetry and RAM data in pediatric subjects

Time frame: through study completion, an average of 6 months

The objective of this clinical investigation is to collect high-resolution pulse oximetry and acoustic signals 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.

Sponsors and collaborators

Lead sponsor

Masimo Corporation

Industry

Registry information

Important dates

Study start: 2016
Primary completion: 2017
Study completion: 2017
First posted: Jan 31, 2017
Registry last updated: May 11, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed