Non-Invasive Respiratory Monitor

Not Applicable

Recruiting

• Conditions: Neuromuscular Diseases; Healthy Volunteers
• Interventions: Device: pneuRIP (breathing with resistance); Device: Respitrace system (Carefusion) (breathing without resistance)

• Registration Number: NCT02851043
• Lead Sponsor: Nemours Children's Clinic

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.

Study Timeline

• Study Start: 2014-08
• Study First Submitted: 2016-07-19
• Study First Submitted QC: 2016-07-29
• Study First Posted: 2016-08-01
• Status Verified: 2024-03
• Last Update Submitted: 2024-11-18
• Last Update Posted: 2024-11-20
• Primary Completion: 2025-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Healthy volunteers
• Neuromuscular disease subjects with mild breathing difficulty
• Capable of following verbal instructions

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Exclusion Criteria

• Severe breathing difficulties

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
pneuRIP(breathing with resistance)	Respitrace system (Carefusion) (breathing without resistance)	Testing the subjects breathing with resistance
pneuRIP(breathing with resistance)	pneuRIP (breathing with resistance)	Testing the subjects breathing with resistance

Primary Outcome Measures

Name	Time	Method
Breathing rate	Immediately after test	The breathing rate is measured by two different monitors

Secondary Outcome Measures

Name	Time	Method
Phase Difference	Immediately after test	The phase difference between the pneuRIP and Respitrace is measured by two different monitors
Labored breathing Index	Immediately after test	The labored breathing index 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

Trial Locations

Locations (1)

Nemours/A.I. duPont Hospital for Children; 🇺🇸 Wilmington, Delaware, United States