Comfort Evaluation of Non-Invasive Respiratory Monitor Interfaces

The University of Alabama at Birmingham

Status and phase: Completed; Early Phase 1

Conditions: Respiratory Device Comfort

Treatments: Device: Respiratory monitor patient interface.

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01494844

X110421003

413525 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Enrollment: 30 patients

Sex: All

Ages: 20 to 49 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

30 participants in 1 patient group

Device interface comfort assessment

Other group

Description:

Single group rates one noninvasive respiratory monitoring interface and then another.

Treatment:

Device: Respiratory monitor patient interface.