Non-Invasive Respiratory Monitor

Nemours Children's Health

Status: Enrolling

Conditions: Healthy Volunteers; Neuromuscular Diseases

Treatments: Device: pneuRIP (breathing with resistance); Device: Respitrace system (Carefusion) (breathing without resistance)

Study type: Interventional

Funder types: Other

Identifiers

NCT02851043

613308

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 estimated patients

Sex: All

Ages: 11 to 17 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• Severe breathing difficulties

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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20 participants in 2 patient groups

pneuRIP(breathing with resistance)

Experimental group

Description:

Testing the subjects breathing with resistance

Treatment:

Device: Respitrace system (Carefusion) (breathing without resistance)

Device: pneuRIP (breathing with resistance)

Respitrace system (Carefusion) (breathing without resistance)

No Intervention group

Description:

Testing subjects breathing without resistance