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Trial record 94 of 5226 for:    neuromuscular disease

Non-Invasive Respiratory Monitor

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ClinicalTrials.gov Identifier: NCT02851043
Recruitment Status : Unknown
Verified July 2016 by Tariq Rahman, Nemours Children's Clinic.
Recruitment status was:  Recruiting
First Posted : August 1, 2016
Last Update Posted : August 1, 2016
Sponsor:
Information provided by (Responsible Party):
Tariq Rahman, 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.

Condition or disease Intervention/treatment Phase
Neuromuscular Diseases Healthy Volunteers Device: pneuRIP (breathing with resistance) Device: Respitrace system (Carefusion) (breathing without resistance) Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Non-Invasive Respiratory Monitor
Study Start Date : August 2014
Estimated Primary Completion Date : September 2016
Estimated Study Completion Date : September 2016

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



Primary Outcome Measures :
  1. Breathing rate [ Time Frame: Immediately after test ]
    The breathing rate is measured by two different monitors


Secondary Outcome Measures :
  1. Labored breathing Index [ Time Frame: Immediately after test ]
    The labored breathing index is measured by two different monitors

  2. Phase Difference [ Time Frame: Immediately after test ]
    The phase difference between the pneuRIP and Respitrace is measured by two different monitors

  3. Percent rib cage [ Time Frame: Immediately after test ]
    The percentage of breathing performed by the rib cage is measured by two different monitors



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Ages Eligible for Study:   11 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Severe breathing difficulties

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02851043


Contacts
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Contact: Tariq Rahman, PhD 302 651 6831 trahman@nemours.org

Locations
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United States, Delaware
Nemours/A.I. duPont Hospital for Children Recruiting
Wilmington, Delaware, United States, 19899
Contact: Tariq Rahman, PhD    302-651-6831    trahman@nemours.org   
Sponsors and Collaborators
Nemours Children's Clinic
Investigators
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Principal Investigator: Thomas Shaffer, PhD Nemours

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Responsible Party: Tariq Rahman, Principal Research Engineer, Nemours Children's Clinic
ClinicalTrials.gov Identifier: NCT02851043     History of Changes
Other Study ID Numbers: 613308
First Posted: August 1, 2016    Key Record Dates
Last Update Posted: August 1, 2016
Last Verified: July 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Neuromuscular Diseases
Nervous System Diseases