NCT02851043

Non-Invasive Respiratory Monitor

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Nemours Children's Clinic · Academic / Other
• Sex: All
• Age: 11 Years – 17 Years
• Healthy volunteers: Accepted

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.

Conditions

• Neuromuscular Diseases
• Healthy Volunteers

Interventions

Type	Name	Description
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

Timeline

• Start date: 2014-08-01
• Primary completion: 2026-12-01
• Completion: 2026-12-01
• First posted: 2016-08-01
• Last updated: 2025-11-21

Locations

1 site across 1 country: United States