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OpenTrials
Completed

NCT Number: NCT01494844

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.

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Key information

Conditions

Respiratory Device Comfort

Age range

20 year–49 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

University of Alabama at Birmingham

Birmingham, Alabama, 35294-1212, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Respiratory monitor patient interface.

Device

Wear each interface for 20 minutes

Other names: Masimo Rainbow Acoustic Monitoring sensor, Oridion Smart Capnoline Plus H sensor

Primary outcomes

  1. Comfort Rating Self-Report Instrument

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

University of Alabama at Birmingham

Other

Collaborators

  • Oridion

Registry information

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Dec 19, 2011
Registry last updated
Aug 9, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.