Non-Invasive Respiratory Monitor
Primary Purpose
Neuromuscular Diseases, Healthy Volunteers
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
pneuRIP (breathing with resistance)
Respitrace system (Carefusion) (breathing without resistance)
Sponsored by
About this trial
This is an interventional diagnostic trial for Neuromuscular Diseases
Eligibility Criteria
Inclusion Criteria:
- Healthy volunteers
- Neuromuscular disease subjects with mild breathing difficulty
- Capable of following verbal instructions
Exclusion Criteria:
- Severe breathing difficulties
Sites / Locations
- Nemours/A.I. duPont Hospital for ChildrenRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
pneuRIP(breathing with resistance)
Respitrace system (Carefusion) (breathing without resistance)
Arm Description
Testing the subjects breathing with resistance
Testing subjects breathing without resistance
Outcomes
Primary Outcome Measures
Breathing rate
The breathing rate is measured by two different monitors
Secondary Outcome Measures
Labored breathing Index
The labored breathing index is measured by two different monitors
Phase Difference
The phase difference between the pneuRIP and Respitrace is measured by two different monitors
Percent rib cage
The percentage of breathing performed by the rib cage is measured by two different monitors
Full Information
NCT ID
NCT02851043
First Posted
July 19, 2016
Last Updated
March 14, 2023
Sponsor
Nemours Children's Clinic
1. Study Identification
Unique Protocol Identification Number
NCT02851043
Brief Title
Non-Invasive Respiratory Monitor
Official Title
Non-Invasive Respiratory Monitor
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 2014 (undefined)
Primary Completion Date
September 2024 (Anticipated)
Study Completion Date
September 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Nemours Children's Clinic
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neuromuscular Diseases, Healthy Volunteers
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
pneuRIP(breathing with resistance)
Arm Type
Experimental
Arm Description
Testing the subjects breathing with resistance
Arm Title
Respitrace system (Carefusion) (breathing without resistance)
Arm Type
No Intervention
Arm Description
Testing subjects breathing without resistance
Intervention Type
Device
Intervention Name(s)
pneuRIP (breathing with resistance)
Intervention Description
subjects are given a resistance element to breath through
Intervention Type
Device
Intervention Name(s)
Respitrace system (Carefusion) (breathing without resistance)
Intervention Description
subjects are asked to breath normally
Primary Outcome Measure Information:
Title
Breathing rate
Description
The breathing rate is measured by two different monitors
Time Frame
Immediately after test
Secondary Outcome Measure Information:
Title
Labored breathing Index
Description
The labored breathing index is measured by two different monitors
Time Frame
Immediately after test
Title
Phase Difference
Description
The phase difference between the pneuRIP and Respitrace is measured by two different monitors
Time Frame
Immediately after test
Title
Percent rib cage
Description
The percentage of breathing performed by the rib cage is measured by two different monitors
Time Frame
Immediately after test
10. Eligibility
Sex
All
Minimum Age & Unit of Time
11 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Healthy volunteers
Neuromuscular disease subjects with mild breathing difficulty
Capable of following verbal instructions
Exclusion Criteria:
Severe breathing difficulties
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tariq Rahman, PhD
Phone
302 651 6831
Email
trahman@nemours.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas Shaffer, PhD
Organizational Affiliation
Nemours
Official's Role
Principal Investigator
Facility Information:
Facility Name
Nemours/A.I. duPont Hospital for Children
City
Wilmington
State/Province
Delaware
ZIP/Postal Code
19899
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tariq Rahman, PhD
Phone
302-651-6831
Email
trahman@nemours.org
12. IPD Sharing Statement
Plan to Share IPD
No
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Non-Invasive Respiratory Monitor
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