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Comfort Evaluation of Non-Invasive Respiratory Monitor Interfaces

Sponsor
University of Alabama at Birmingham (Other)
Overall Status
Completed
CT.gov ID
NCT01494844
Collaborator
Oridion (Industry)
30
Enrollment
1
Location
1
Arm
3
Duration (Months)
9.9
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Respiratory monitor patient interface.
 Early Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
30 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Official Title:
Comfort Evaluation of Non-Invasive Respiratory Monitor Interfaces
Study Start Date :
Jun 1, 2011
Actual Primary Completion Date :
Sep 1, 2011
Actual Study Completion Date :
Sep 1, 2011

Arms and Interventions

Arm Intervention/Treatment
Other: 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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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).

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 49 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Locations

    Site City State Country Postal Code
    1 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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Jonathan B. Waugh, PhD, Principal Investigator, University of Alabama at Birmingham
    ClinicalTrials.gov Identifier:
    NCT01494844
    Other Study ID Numbers:
    • X110421003
    • 413525
    First Posted:
    Dec 19, 2011
    Last Update Posted:
    Aug 9, 2013
    Last Verified:
    Aug 1, 2013
    Keywords provided by Jonathan B. Waugh, PhD, Principal Investigator, University of Alabama at Birmingham
    Patient Monitoring
    Capnography
    Human Engineering

    Study Results

    No Results Posted as of Aug 9, 2013