Sleep Apnea
Conditions
Brief summary
To capture high resolution waveform data and numerical data from investigational and FDA-released RAM sensors in the neonatal, infant, pediatric, and adult patient population
Interventions
DEVICERAM sensor
Rainbow Acoustic Monitoring sensor for measurement of respiratory rate
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 70 Years
Healthy volunteers
No
Inclusion criteria
* Male or Female subjects that are between 0 to 70 years old. * Neonate, Infant, Pediatric, Adult, and Pregnant subjects with fully developed skin.
Exclusion criteria
* Patients with skin abnormalities at the planned application sites that would interfere with sensor, cannula or electrode applications. * Patients 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). * Patients who the PI deems ineligible at the PI's discretion
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of subjects in which respiratory rate is collected | Duration of surgery | Capture high resolution waveform data and numerical data from respiratory rate using RAM sensor |
Countries
United States
Outcome results
None listed