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Comfort Evaluation of Non-Invasive Respiratory Monitor Interfaces

NCT ID: NCT01494844

Last Updated: 2013-08-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-06-30

Study Completion Date

2011-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Respiratory Device Comfort

Keywords

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Patient Monitoring Capnography Human Engineering

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Blinding Strategy

NONE

Study Groups

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Device interface comfort assessment

Single group rates one noninvasive respiratory monitoring interface and then another.

Group Type OTHER

Respiratory monitor patient interface.

Intervention Type DEVICE

Wear each interface for 20 minutes

Interventions

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Respiratory monitor patient interface.

Wear each interface for 20 minutes

Intervention Type DEVICE

Other Intervention Names

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Masimo Rainbow Acoustic Monitoring sensor Oridion Smart Capnoline Plus H sensor

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

49 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Oridion

INDUSTRY

Sponsor Role collaborator

University of Alabama at Birmingham

OTHER

Sponsor Role lead

Responsible Party

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Jonathan B. Waugh, PhD

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jonathan B Waugh, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Alabama at Birmingham

Locations

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University of Alabama at Birmingham

Birmingham, Alabama, United States

Site Status

Countries

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United States

References

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Waugh JB, Epps CA. Comfort evaluation of noninvasive respiratory monitoring interfaces. Respir Care 2011; 56(10): 1722.

Reference Type RESULT

Other Identifiers

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413525

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

X110421003

Identifier Type: -

Identifier Source: org_study_id