Use of Rainbow Acoustic Monitoring in Pediatric Patients – A Clinical Engineering Data Collection Protocol
Overview
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).
Full Title of Study: “Use of Rainbow Acoustic Monitoring in Pediatric Patients – A Clinical Engineering Data Collection Protocol”
Study Type
- Study Type: Interventional
- Study Design
- Allocation: N/A
- Intervention Model: Single Group Assignment
- Primary Purpose: Other
- Masking: None (Open Label)
- Study Primary Completion Date: January 20, 2015
Interventions
- Device: RAM sensor
- Acoustic Respiration Monitor
Arms, Groups and Cohorts
- Experimental: Test Subjects
- All test subjects were pediatric patients following general anesthesia who received the RAM sensor which measures respiration rate.
Clinical Trial Outcome Measures
Primary Measures
- Accuracy of RAM sensor to detect respiration rate
- Time Frame: 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.
Participating in This Clinical Trial
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
Gender Eligibility: All
Minimum Age: N/A
Maximum Age: 18 Years
Are Healthy Volunteers Accepted: No
Investigator Details
- Lead Sponsor
- Masimo Corporation
- Provider of Information About this Clinical Study
- Sponsor
Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.