Comfort Evaluation of Non-Invasive Respiratory Monitor Interfaces

Early Phase 1

Completed

• Conditions: Respiratory Device Comfort
• Interventions: Device: Respiratory monitor patient interface.

• Registration Number: NCT01494844
• Lead Sponsor: University of Alabama at Birmingham

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2011-06
• Primary Completion: 2011-09
• Study Completion: 2011-09
• Study First Submitted: 2011-12-15
• Study First Submitted QC: 2011-12-15
• Study First Posted: 2011-12-19
• Status Verified: 2013-08
• Last Update Submitted: 2013-08-07
• Last Update Posted: 2013-08-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Device interface comfort assessment	Respiratory monitor patient interface.	Single group rates one noninvasive respiratory monitoring interface and then another.

Primary Outcome Measures

Name	Time	Method
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).

Trial Locations

Locations (1)

University of Alabama at Birmingham; 🇺🇸 Birmingham, Alabama, United States