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Comfort Evaluation of Non-Invasive Respiratory Monitor Interfaces

NCT01494844 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2013-08-09

No results posted yet for this study

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.

Conditions

  • Respiratory Device Comfort

Interventions

DEVICE

Respiratory monitor patient interface.

Wear each interface for 20 minutes

Sponsors & Collaborators

  • Oridion

    collaborator INDUSTRY

  • University of Alabama at Birmingham

    lead OTHER

Principal Investigators

  • Jonathan B Waugh, PhD · University of Alabama at Birmingham

Study Design

Allocation
NA
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
20 Years
Max Age
49 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-06-30
Primary Completion
2011-09-30
Completion
2011-09-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01494844 on ClinicalTrials.gov