Plethysmographic and Acoustic Respiration Rate Clinical Data Collection

Masimo Corporation1 site in 1 country200 target enrollmentDecember 2016

ConditionsHealthy

Overview

Phase: N/A
Intervention: Not specified
Conditions: Healthy
Sponsor: Masimo Corporation
Enrollment: 200
Locations: 1
Primary Endpoint: Collection of high-resolution pulse oximetry and RAM data in pediatric subjects
Status: Completed
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

December 2016

End Date

March 2017

Last Updated

4 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Masimo Corporation

Responsible Party

Sponsor

Eligibility Criteria

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

Outcomes

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.