Comfort Evaluation of Non-Invasive Respiratory Monitor Interfaces

Completed · Early Phase 1

Conditions studied: Respiratory Device Comfort

In brief

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.

Key facts

Study ID

NCT01494844

Run by

University of Alabama at Birmingham

People needed

30

Starts

2011-06-01

Expected to finish

2011-09-01

Last updated by the study team

2013-08-09

Who can join

Age: 20 and older, up to 49. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• Any injury or condition that would affect assessment of comfort.

Where it is running

• University of Alabama at Birmingham — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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