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Comfort Evaluation of Non-Invasive Respiratory Monitor Interfaces

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Oridion
Information provided by (Responsible Party):
Jonathan B. Waugh, PhD, University of Alabama at Birmingham
ClinicalTrials.gov Identifier:
NCT01494844
First received: December 15, 2011
Last updated: December 16, 2011
Last verified: December 2011
History of Changes
  Purpose

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.


Condition Intervention Phase
Respiratory Device Comfort
 Device: Respiratory monitor patient interface.
 Phase 0

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: Comfort Evaluation of Non-Invasive Respiratory Monitor Interfaces

Further study details as provided by University of Alabama at Birmingham:

Primary Outcome Measures:
  • Comfort Rating Self-Report Instrument [ Time Frame: 5 Minutes ] [ Designated as safety issue: No ]
    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).


Estimated Enrollment: 30
Study Start Date: June 2011
Estimated Study Completion Date: May 2012
Estimated Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Device interface comfort assessment
Single group rates one noninvasive respiratory monitoring interface and then another.
 Device: Respiratory monitor patient interface.
Wear each interface for 20 minutes
Other Names:
  • Masimo Rainbow Acoustic Monitoring sensor
  • Oridion Smart Capnoline Plus H sensor

  Eligibility

Ages Eligible for Study:   19 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01494844

Locations
United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294-1212
Sponsors and Collaborators
University of Alabama at Birmingham
Oridion
Investigators
Principal Investigator: Jonathan B Waugh, PhD University of Alabama at Birmingham
  More Information

No publications provided

Responsible Party: Jonathan B. Waugh, PhD, Principal Investigator, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT01494844     History of Changes
Other Study ID Numbers: X110421003, 413525
Study First Received: December 15, 2011
Last Updated: December 16, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by University of Alabama at Birmingham:
Patient Monitoring
Capnography
Human Engineering

ClinicalTrials.gov processed this record on June 18, 2013