Comfort Evaluation of Non-Invasive Respiratory Monitor Interfaces
2 other identifiers
interventional
30
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for early_phase_1
Started Jun 2011
Shorter than P25 for early_phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2011
CompletedFirst Submitted
Initial submission to the registry
December 15, 2011
CompletedFirst Posted
Study publicly available on registry
December 19, 2011
CompletedAugust 9, 2013
August 1, 2013
3 months
December 15, 2011
August 7, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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).
5 Minutes
Study Arms (1)
Device interface comfort assessment
OTHERSingle group rates one noninvasive respiratory monitoring interface and then another.
Interventions
Wear each interface for 20 minutes
Eligibility Criteria
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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Alabama at Birminghamlead
- Oridioncollaborator
Study Sites (1)
University of Alabama at Birmingham
Birmingham, Alabama, 35294-1212, United States
Related Publications (1)
Waugh JB, Epps CA. Comfort evaluation of noninvasive respiratory monitoring interfaces. Respir Care 2011; 56(10): 1722.
RESULT
Study Officials
- PRINCIPAL INVESTIGATOR
Jonathan B Waugh, PhD
University of Alabama at Birmingham
Study Design
- Study Type
- interventional
- Phase
- early phase 1
- Allocation
- NA
- Masking
- NONE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
December 15, 2011
First Posted
December 19, 2011
Study Start
June 1, 2011
Primary Completion
September 1, 2011
Study Completion
September 1, 2011
Last Updated
August 9, 2013
Record last verified: 2013-08