Non-Invasive Respiratory Monitor

Healthy Volunteers Clinical Trial

Official title:

Non-Invasive Respiratory Monitor

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02851043
• Other study ID #: 613308
• Status: Recruiting
• Phase: N/A
• Start date: August 2014
• Est. completion date: September 2024

Study information

• Verified date: March 2024
• Source: Nemours Children's Clinic
• Contact: Tariq Rahman, PhD
• Phone: 302 651 6831
• Email: trahman[@]nemours.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: September 2024
• Est. primary completion date: September 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 11 Years to 17 Years

Eligibility

Inclusion Criteria:

• Healthy volunteers

• Neuromuscular disease subjects with mild breathing difficulty

• Capable of following verbal instructions

Exclusion Criteria:

• Severe breathing difficulties

Related Conditions & MeSH terms

• Healthy Volunteers
• Neuromuscular Diseases

Intervention

Device:
• pneuRIP (breathing with resistance)
subjects are given a resistance element to breath through
• Respitrace system (Carefusion) (breathing without resistance)
subjects are asked to breath normally

Locations

Country	Name	City	State
United States	Nemours/A.I. duPont Hospital for Children	Wilmington	Delaware

Sponsors (1)

Lead Sponsor	Collaborator
Nemours Children's Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Breathing rate	The breathing rate is measured by two different monitors	Immediately after test
Secondary	Labored breathing Index	The labored breathing index is measured by two different monitors	Immediately after test
Secondary	Phase Difference	The phase difference between the pneuRIP and Respitrace is measured by two different monitors	Immediately after test
Secondary	Percent rib cage	The percentage of breathing performed by the rib cage is measured by two different monitors	Immediately after test