Rainbow Acoustic Monitoring (RAM) Clinical Engineering Data Collection
Overview
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
Study Type
- Study Type: Interventional
- Study Design
- Allocation: N/A
- Intervention Model: Single Group Assignment
- Primary Purpose: Device Feasibility
- Masking: None (Open Label)
- Study Primary Completion Date: October 2018
Interventions
- Device: RAM sensor
- Rainbow Acoustic Monitoring sensor for measurement of respiratory rate
Arms, Groups and Cohorts
- Experimental: Test group
- The subjects will be enrolled into the test group and will receive RAM sensor.
Clinical Trial Outcome Measures
Primary Measures
- Number of subjects in which respiratory rate is collected
- Time Frame: Duration of surgery
- Capture high resolution waveform data and numerical data from respiratory rate using RAM sensor
Participating in This Clinical Trial
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
Gender Eligibility: All
Minimum Age: N/A
Maximum Age: 70 Years
Are Healthy Volunteers Accepted: No
Investigator Details
- Lead Sponsor
- Masimo Corporation
- Provider of Information About this Clinical Study
- Sponsor
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