Respiratory Device Comfort
Conditions
Keywords
Patient Monitoring, Capnography, Human Engineering
Brief summary
This research study will test the comfort of two noninvasive respiratory monitoring sensors (the connection to a monitor worn by a person-not the monitor). The two sensors, Masimo Rainbow Acoustic Monitoring sensor and Oridion Smart Capnoline Plus H sensor, are cleared by the U.S. Food and Drug Administration (FDA) and currently used in the clinical setting. People who enter into the study will wear the two interfaces, one after the other, for 20 minutes each (10 minutes with a small flow of air to the nostrils and 10 minutes without) and rate the comfort of each with a seven question survey. A total of 30 participants will be recruited.
Interventions
DEVICERespiratory monitor patient interface.
Wear each interface for 20 minutes
Sponsors
Oridion
University of Alabama at Birmingham
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 49 Years
Healthy volunteers
Yes
Inclusion criteria
* Normal body temperature * Between the ages of 19-65 years * Self-report as feeling to be in typical health * No skin irritation face or neck where a sensor would be placed. * School of Health Professions student
Exclusion criteria
* Any injury or condition that would affect assessment of comfort.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Comfort Rating Self-Report Instrument | 5 Minutes | A seven-question written instrument constructed in the style of descriptive analogue to evaluate multiple facets of device comfort. Answer choices allow either ordinal ranking (one requires a ranking on a continuous time scale). |
Countries
United States
Outcome results
None listed