Comfort Evaluation of Non-Invasive Respiratory Monitor Interfaces

Early Phase 1CompletedNCT01494844

University of Alabama at Birmingham30 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Masking

NONE

Enrollment

Conditions

Respiratory Device Comfort

Interventions

Respiratory monitor patient interface.

Eligibility

Sex: ALLMin age: 20 YearsMax age: 49 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Comfort Rating Self-Report Instrument

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).

Time frame: 5 Minutes