Use of Rainbow Acoustic Monitoring in Pediatric Patients - A Clinical Engineering Data Collection Protocol

Masimo Corporation1 site in 1 country170 target enrollmentAugust 4, 2011

ConditionsSurgery

Overview

Phase: N/A
Intervention: Not specified
Conditions: Surgery
Sponsor: Masimo Corporation
Enrollment: 170
Locations: 1
Primary Endpoint: Accuracy of RAM sensor to detect respiration rate
Status: Completed
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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).

Registry

clinicaltrials.gov

Start Date

August 4, 2011

End Date

July 24, 2015

Last Updated

7 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Masimo Corporation

Responsible Party

Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

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.