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

Masimo

Status: Completed

Conditions: Surgery

Treatments: Device: RAM sensor

Study type: Interventional

Funder types: Industry

Identifiers

NCT03128827

SZMU0002

Details and patient eligibility

About

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).

Enrollment: 170 patients

Sex: All

Ages: Under 18 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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170 participants in 1 patient group

Test Subjects

Experimental group

Description:

All test subjects were pediatric patients following general anesthesia who received the RAM sensor which measures respiration rate.

Treatment:

Device: RAM sensor