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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