Rainbow Acoustic Monitoring (RAM) Clinical Engineering Data Collection

Masimo Corporation1 site in 1 country78 target enrollmentJune 2016

ConditionsSleep Apnea

Overview

Phase: N/A
Intervention: Not specified
Conditions: Sleep Apnea
Sponsor: Masimo Corporation
Enrollment: 78
Locations: 1
Primary Endpoint: Number of subjects in which respiratory rate is collected
Status: Terminated
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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

Registry

clinicaltrials.gov

Start Date

June 2016

End Date

October 2018

Last Updated

4 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Masimo Corporation

Responsible Party

Sponsor

Eligibility Criteria

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