Use of Rainbow Acoustic Monitoring in Pediatric Patients - A Clinical Engineering Data Collection Protocol
Not Applicable
Completed
- Conditions
- Surgery
- Registration Number
- NCT03128827
- Lead Sponsor
- Masimo Corporation
- 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 170
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Children's Medical Center Dallas
🇺🇸Dallas, Texas, United States
Children's Medical Center Dallas🇺🇸Dallas, Texas, United States