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

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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)

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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