Non-Invasive Respiratory Monitor

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.

Study Overview

• Status: Recruiting
• Conditions: Neuromuscular Diseases; Healthy Volunteers
• Intervention / Treatment: Device: pneuRIP (breathing with resistance); Device: Respitrace system (Carefusion) (breathing without resistance)

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 Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Tariq Rahman, PhD; Phone Number: 302 651 6831; Email: trahman@nemours.org

Study Locations

• United States
  • Delaware
    • Wilmington, Delaware, United States, 19899
      • Recruiting
      • Nemours/A.I. duPont Hospital for Children
      • Contact: Tariq Rahman, PhD; Phone Number: 302-651-6831; Email: trahman@nemours.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 11 years to 17 years (Child)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

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

Exclusion Criteria:

• Severe breathing difficulties

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Breathing rate	The breathing rate is measured by two different monitors	Immediately after test

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Labored breathing Index	The labored breathing index is measured by two different monitors	Immediately after test
Phase Difference	The phase difference between the pneuRIP and Respitrace is measured by two different monitors	Immediately after test
Percent rib cage	The percentage of breathing performed by the rib cage is measured by two different monitors	Immediately after test

Collaborators and Investigators

• Sponsor: Nemours Children's Clinic
• Investigators: Principal Investigator: Thomas Shaffer, PhD, Nemours

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2014
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: July 19, 2016
• First Submitted That Met QC Criteria: July 29, 2016
• First Posted (Estimated): August 1, 2016

Study Record Updates

• Last Update Posted (Estimated): November 21, 2025
• Last Update Submitted That Met QC Criteria: November 19, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neuromuscular Diseases
• Other Study ID Numbers: 613308

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO