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Recruiting NCT02851043

Non-Invasive Respiratory Monitor

No phase Interventional Neuromuscular Diseases Healthy Volunteers

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: pneuRIP (breathing with resistance), Respitrace system (Carefusion) (breathing without resistance).
Who it may be relevant to
Registry conditions: Neuromuscular Diseases, Healthy Volunteers. Basic parameters: 11 years — 17 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Overview

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.

Interventions

  • 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

Primary outcome measures

  • Breathing rate [Time frame: Immediately after test]
Secondary outcome measures (3)
  • Labored breathing Index [Time frame: Immediately after test]
  • Phase Difference [Time frame: Immediately after test]
  • Percent rib cage [Time frame: Immediately after test]

Eligibility criteria

Inclusion criteria

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

Exclusion criteria

  • Severe breathing difficulties

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Diagnostic

Study locations

United States · 1 center
  • Nemours/A.I. duPont Hospital for Children — Wilmington

Identifiers

NCT: NCT02851043 · 613308

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗