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Clinical Trials/NCT02851043
NCT02851043
Recruiting
N/A

Non-Invasive Respiratory Monitor

Nemours Children's Clinic1 site in 1 country20 target enrollmentAugust 1, 2014

Overview

Phase
N/A
Intervention
Not specified
Conditions
Neuromuscular Diseases
Sponsor
Nemours Children's Clinic
Enrollment
20
Locations
1
Primary Endpoint
Breathing rate
Status
Recruiting
Last Updated
5 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
August 1, 2014
End Date
December 1, 2026
Last Updated
5 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Tariq Rahman

Principal Research Engineer

Nemours Children's Clinic

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

  • Severe breathing difficulties

Outcomes

Primary Outcomes

Breathing rate

Time Frame: Immediately after test

The breathing rate is measured by two different monitors

Secondary Outcomes

  • Phase Difference(Immediately after test)
  • Labored breathing Index(Immediately after test)
  • Percent rib cage(Immediately after test)

Study Sites (1)

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