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NCT Number: NCT02851043

Non-Invasive Respiratory Monitor

This study will clinically evaluate a newly developed respiratory monitor - pneuRIP. The pneuRIP uses Respiratory Inductance Plethysmography (RIP) bands to measure key breathing indices non-invasively. This study compares the pneuRIP to an existing Respitrace system (Carefusion, Yorba Linda CA). 10 normal children and 10 children with breathing difficulties will be monitored with both systems.

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Key information

Conditions

Neuromuscular Diseases Healthy Volunteers Nervous System Diseases

Age range

11 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Nemours/A.I. duPont Hospital for Children

Wilmington, Delaware, 19899, United States

Location status: Recruiting

Location contact

Tariq Rahman, PhD

CONTACT

[email protected]

302-651-6831

About this study

Firstly, ten healthy children will participate in a trial to evaluate the pneuRIP. They will be fitted with the bands around their abdomen and chest. The pneuRIP will be connected to the bands through electrodes. Breathing is then measured wirelessly with an iPad. They will be asked to lie down. They are asked to breath normally then asked to breath with a resistive elements to place in their mouth. The resistive elements makes it difficult to breath (similar to breathing through a straw). They will breathe for 3 minutes for both conditions as we record their breathing with the pneuRIP and the Respitrace. These data will be compared.

Secondly, A group of 10 subjects from the outpatient muscle clinic will be fitted with the chest and abdomen bands. The Respitrace monitor and the pneuRIP will record their breathing patterns. Data from the two systems will then be compared.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Healthy volunteers
  • Neuromuscular disease subjects with mild breathing difficulty
  • Capable of following verbal instructions

Exclusion criteria

  • Severe breathing difficulties

Treatment and study plan

pneuRIP (breathing with resistance)

Device

subjects are given a resistance element to breath through

Respitrace system (Carefusion) (breathing without resistance)

Device

subjects are asked to breath normally

Primary outcomes

  1. Breathing rate

    Time frame: Immediately after test

    The breathing rate is measured by two different monitors

Secondary outcomes

  1. Labored breathing Index

    Time frame: Immediately after test

    The labored breathing index is measured by two different monitors

  2. Phase Difference

    Time frame: Immediately after test

    The phase difference between the pneuRIP and Respitrace is measured by two different monitors

  3. Percent rib cage

    Time frame: Immediately after test

    The percentage of breathing performed by the rib cage is measured by two different monitors

Study contacts

Contact information is provided by the study sponsor or research team.

Tariq Rahman, PhD

CONTACT

[email protected]

302 651 6831

Sponsors and collaborators

Lead sponsor

Nemours Children's Clinic

Other

Registry information

Important dates

Study start
2014
Primary completion
2026
Study completion
2026
First posted
Aug 1, 2016
Registry last updated
Nov 21, 2025

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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