Non-Invasive Respiratory Monitor
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: pneuRIP(breathing with resistance) Testing the subjects breathing with resistance |
Device: pneuRIP (breathing with resistance)
subjects are given a resistance element to breath through
Device: Respitrace system (Carefusion) (breathing without resistance)
subjects are asked to breath normally
|
| No Intervention: Respitrace system (Carefusion) (breathing without resistance) Testing subjects breathing without resistance |
Outcome Measures
Primary Outcome Measures
- Breathing rate [Immediately after test]
The breathing rate is measured by two different monitors
Secondary Outcome Measures
- 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
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Healthy volunteers
-
Neuromuscular disease subjects with mild breathing difficulty
-
Capable of following verbal instructions
Exclusion Criteria:
- Severe breathing difficulties
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Nemours/A.I. duPont Hospital for Children | Wilmington | Delaware | United States | 19899 |
Sponsors and Collaborators
- Nemours Children's Clinic
Investigators
- Principal Investigator: Thomas Shaffer, PhD, Nemours
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 613308