Plethysmographic and Acoustic Respiration Rate Clinical Data Collection
Not Applicable
Completed
- Conditions
- Healthy
- Registration Number
- NCT03038074
- Lead Sponsor
- Masimo Corporation
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 200
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Medical Office of Mohammad T. Bailony
🇺🇸National City, California, United States
Medical Office of Mohammad T. Bailony🇺🇸National City, California, United States