An interventional study of pneuRIP (breathing with resistance) and Respitrace system (Carefusion) (breathing without resistance) in Neuromuscular Diseases and Healthy Volunteers, sponsored by Nemours Children's Clinic. Recruiting at 1 site in United States. Open to participants aged 11 Years to 17 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-11-21.
Sponsored by Nemours Children's Clinic · Not applicable, Interventional, and Diagnostic
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.
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.
300 studies on the registry are indexed under Neuromuscular Diseases; 87 are open to participants now.
This study's planned enrollment of 20 is below the median of 32 across 168 interventional studies indexed under Neuromuscular Diseases.
Browse Neuromuscular Diseases studies →Nemours Children's Clinic is the lead sponsor of 127 studies on the registry; 27 are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 6 (67%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Testing the subjects breathing with resistance
Device: pneuRIP (breathing with resistance) · Device: Respitrace system (Carefusion) (breathing without resistance)
Testing subjects breathing without resistance
subjects are given a resistance element to breath through
subjects are asked to breath normally
Breathing rate
The breathing rate is measured by two different monitors
Time frame: Immediately after test
Labored breathing Index
The labored breathing index is measured by two different monitors
Time frame: Immediately after test
Phase Difference
The phase difference between the pneuRIP and Respitrace is measured by two different monitors
Time frame: Immediately after test
Percent rib cage
The percentage of breathing performed by the rib cage is measured by two different monitors
Time frame: Immediately after test
Plan to share: No
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