Non-Invasive Respiratory Monitor

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Non-Invasive Respiratory Monitor

Conditions
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Neuromuscular Diseases, Healthy Volunteers

Intervention / Treatment
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* Device: pneuRIP (breathing with resistance)
* Device: Respitrace system (Carefusion) (breathing without resistance)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy volunteers Neuromuscular disease subjects with mild breathing difficulty Capable of following verbal instructions Exclusion Criteria: Severe breathing difficulties

Ages Eligible for Study
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Minimum Age: 11 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: pneuRIP(breathing with resistance)<br>Testing the subjects breathing with resistance | Device: pneuRIP (breathing with resistance)<br>* subjects are given a resistance element to breath through<br>Device: Respitrace system (Carefusion) (breathing without resistance)<br>* subjects are asked to breath normally<br>|
| No Intervention: Respitrace system (Carefusion) (breathing without resistance)<br>Testing subjects breathing without resistance | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Breathing rate | The breathing rate is measured by two different monitors | Immediately after test | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Labored breathing Index | The labored breathing index is measured by two different monitors | Immediately after test | 
| Phase Difference | The phase difference between the pneuRIP and Respitrace is measured by two different monitors | Immediately after test | 
| Percent rib cage | The percentage of breathing performed by the rib cage is measured by two different monitors | Immediately after test |