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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

Tracking Information
First Submitted Date  ICMJE July 19, 2016
First Posted Date  ICMJE August 1, 2016
Last Update Posted Date August 1, 2016
Study Start Date  ICMJE August 2014
Estimated Primary Completion Date September 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 29, 2016)
Breathing rate [ Time Frame: Immediately after test ]
The breathing rate is measured by two different monitors
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: July 29, 2016)
  • Labored breathing Index [ Time Frame: Immediately after test ]
    The labored breathing index is measured by two different monitors
  • Phase Difference [ Time Frame: Immediately after test ]
    The phase difference between the pneuRIP and Respitrace is measured by two different monitors
  • Percent rib cage [ Time Frame: Immediately after test ]
    The percentage of breathing performed by the rib cage is measured by two different monitors
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Non-Invasive Respiratory Monitor
Official Title  ICMJE Non-Invasive Respiratory Monitor
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE
  • Neuromuscular Diseases
  • Healthy Volunteers
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Experimental: pneuRIP(breathing with resistance)
    Testing the subjects breathing with resistance
    Interventions:
    • Device: pneuRIP (breathing with resistance)
    • Device: Respitrace system (Carefusion) (breathing without resistance)
  • No Intervention: Respitrace system (Carefusion) (breathing without resistance)
    Testing subjects breathing without resistance
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: July 29, 2016)
20
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 2016
Estimated Primary Completion Date September 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

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

Exclusion Criteria:

  • Severe breathing difficulties
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 11 Years to 17 Years   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02851043
Other Study ID Numbers  ICMJE 613308
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Tariq Rahman, Nemours Children's Clinic
Study Sponsor  ICMJE Nemours Children's Clinic
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Thomas Shaffer, PhD Nemours
PRS Account Nemours Children's Clinic
Verification Date July 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP