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

Masimo Corporation170 enrolled

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).

Study Type

INTERVENTIONAL

Allocation

Purpose

OTHER

Masking

NONE

Enrollment

170

Conditions

Surgery

Interventions

RAM sensorDEVICE

Acoustic Respiration Monitor

Eligibility

Sex: ALLMax age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Children's Medical Center Dallas

Dallas, Texas, United States

Outcomes

Primary Outcomes

Accuracy of RAM sensor to detect respiration rate

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.

Time frame: 1-6 hours

Data from ClinicalTrials.gov

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