Non-Invasive Respiratory Monitor
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age11-17
SponsorNemours Children's Clinic
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Healthy volunteers
Neuromuscular disease subjects with mild breathing difficulty
Capable of following verbal instructions
Disqualifiers
Severe breathing difficulties
Trial design
Design model
Parallel
Treatments tested in this trial
pneuRIP (breathing with resistance)
Devicesubjects are given a resistance element to breath through
Respitrace system (Carefusion) (breathing without resistance)
Devicesubjects are asked to breath normally
Treatment groups
20 Participants
are divided into 2 treatment groupsGroup A: pneuRIP(breathing with resistance)Experimental treatment 2 interventions
Group B: Respitrace system (Carefusion) (breathing without resistance)No intervention 0 interventions
Trial outcomes
Primary outcomes
1
Breathing rate
The breathing rate is measured by two different monitors
Time frame
Immediately after testSecondary outcomes
1
Labored breathing Index
The labored breathing index is measured by two different monitors
Time frame
Immediately after test2
Phase Difference
The phase difference between the pneuRIP and Respitrace is measured by two different monitors
Time frame
Immediately after test3
Percent rib cage
The percentage of breathing performed by the rib cage is measured by two different monitors
Time frame
Immediately after testSponsors and contacts
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Source ClinicalTrials.gov