Healthy
Conditions
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.
Interventions
DEVICEPulse Oximeter with respiration rate sensor
Sponsors
Masimo Corporation
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
No minimum to 5 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Collection of high-resolution pulse oximetry and RAM data in pediatric subjects | 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. |
Countries
United States
Outcome results
None listed