Non-Invasive Respiratory Monitor

NCT ID: NCT02851043

Last Updated: 2025-11-21

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-08-31
• Study Completion Date: 2026-12-31

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.

Conditions

Neuromuscular Diseases; Healthy Volunteers

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

pneuRIP(breathing with resistance)

Testing the subjects breathing with resistance

Group Type: EXPERIMENTAL

pneuRIP (breathing with resistance)

Intervention Type: DEVICE

subjects are given a resistance element to breath through

Respitrace system (Carefusion) (breathing without resistance)

Intervention Type: DEVICE

subjects are asked to breath normally

Respitrace system (Carefusion) (breathing without resistance)

Testing subjects breathing without resistance

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

pneuRIP (breathing with resistance)

subjects are given a resistance element to breath through

Intervention Type: DEVICE

Respitrace system (Carefusion) (breathing without resistance)

subjects are asked to breath normally

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• Severe breathing difficulties

• Minimum Eligible Age: 11 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Nemours Children's Clinic

OTHER

Sponsor Role: lead

Responsible Party

Tariq Rahman

Principal Research Engineer

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Thomas Shaffer, PhD

Role: PRINCIPAL_INVESTIGATOR

Nemours

Locations

Nemours/A.I. duPont Hospital for Children

Wilmington, Delaware, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Tariq Rahman, PhD

Role: CONTACT

trahman@nemours.org

302 651 6831

Facility Contacts

Tariq Rahman, PhD

Role: primary

trahman@nemours.org

302-651-6831

Other Identifiers

613308

Identifier Type: -

Identifier Source: org_study_id