Text Size

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

December 15, 2011
December 16, 2011
June 2011
May 2012   (final data collection date for primary outcome measure)
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).
Same as current
Complete list of historical versions of study NCT01494844 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Comfort Evaluation of Non-Invasive Respiratory Monitor Interfaces
Comfort Evaluation of Non-Invasive Respiratory Monitor Interfaces

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.
Not Provided
Interventional
Phase 0
Intervention Model: Single Group Assignment
Masking: Open Label
Respiratory Device Comfort
Device: Respiratory monitor patient interface.
Wear each interface for 20 minutes
Other Names:
  • Masimo Rainbow Acoustic Monitoring sensor
  • Oridion Smart Capnoline Plus H sensor
Device interface comfort assessment
Single group rates one noninvasive respiratory monitoring interface and then another.
Intervention: Device: Respiratory monitor patient interface.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
30
May 2012
May 2012   (final data collection date for primary outcome measure)

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.
Both
19 Years to 65 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01494844
X110421003, 413525
No
Jonathan B. Waugh, PhD, University of Alabama at Birmingham
University of Alabama at Birmingham
Oridion
Principal Investigator: Jonathan B Waugh, PhD University of Alabama at Birmingham
University of Alabama at Birmingham
December 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP