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Completed

NCT Number: NCT03128827

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

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).

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Key information

Conditions

Surgery

Age range

Up to 18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Children's Medical Center Dallas

Dallas, Texas, 75235, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

RAM sensor

Device

Acoustic Respiration Monitor

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Masimo Corporation

Industry

Registry information

Important dates

Study start
2011
Primary completion
2015
Study completion
2015
First posted
Apr 25, 2017
Registry last updated
Oct 22, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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