Healthy Volunteers, Neuromuscular Diseases
Conditions
Brief summary
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
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.
Interventions
DEVICEpneuRIP (breathing with resistance)
subjects are given a resistance element to breath through
DEVICERespitrace system (Carefusion) (breathing without resistance)
subjects are asked to breath normally
Sponsors
Nemours Children's Clinic
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
11 Years to 17 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy volunteers * Neuromuscular disease subjects with mild breathing difficulty * Capable of following verbal instructions
Exclusion criteria
* Severe breathing difficulties
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Breathing rate | Immediately after test | The breathing rate is measured by two different monitors |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Labored breathing Index | Immediately after test | The labored breathing index is measured by two different monitors |
| Phase Difference | Immediately after test | The phase difference between the pneuRIP and Respitrace is measured by two different monitors |
| Percent rib cage | Immediately after test | The percentage of breathing performed by the rib cage is measured by two different monitors |
Countries
United States
Contacts
Primary ContactTariq Rahman, PhD
Outcome results
None listed