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

Completed · Not applicable

Conditions studied: Surgery

In brief

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).

Key facts

Study ID

NCT03128827

Run by

Masimo Corporation

People needed

170

Starts

2011-08-04

Expected to finish

2015-07-24

Last updated by the study team

2018-10-22

Who can join

Age: any, up to 18. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Children's Medical Center Dallas — Dallas, Texas, United States

Full record on ClinicalTrials.gov

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