Surgery
Conditions
Brief summary
The study will capture high resolution waveform data and numerical data from three respiratory rate methods: end tidal CO2, impedance pneumography, and bioacoustic sensing (Rainbow Acoustic Monitoring, RAM).
Interventions
DEVICERAM sensor
Acoustic Respiration Monitor
Sponsors
Masimo Corporation
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
No minimum to 18 Years
Healthy volunteers
No
Inclusion criteria
* 0 to 18 years old inclusive, male and female patients * Only patients with written informed consent signed by parents or legal guardians will be enrolled * In children 10 and older, patient's assent will be obtained
Exclusion criteria
* Patients who are unable to give their consent and/or assent * Patients with skin abnormalities (rash, eczema, etc) at the planned application sites that would interfere with sensor, cannula or electrode applications
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Accuracy of RAM sensor to detect respiration rate | 1-6 hours | Accuracy will be determined by comparing the noninvasive respiratory rate measurement of the sensor to that obtained from a reference and calculating the arithmetic root mean square (Arms) error value. |
Countries
United States
Outcome results
None listed