Comfort Evaluation of Non-Invasive Respiratory Monitor In... | NCT01494844

Studies
Comfort Evaluation of Non-Invasive Respiratory Monitor Interfaces

NCT01494844

Sponsor

University of Alabama at Birmingham

Status

Completed

Last Update Posted

Aug 9, 2013Estimated

Enrollment

30Actual

Phase

Early Phase 1

Conditions

Respiratory Device Comfort

Interventions

Respiratory monitor patient interface.

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
413525	Other Grant/Funding Number	Oridion Capnography Inc.

Status Module

Record Verification Date

Aug 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2011

Primary Completion Date

Sep 2011Actual

Completion Date

Sep 2011Actual

First Submitted Date

Dec 15, 2011

First Submission Date that Met QC Criteria

Dec 15, 2011

First Posted Date

Dec 19, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 7, 2013

Last Update Posted Date

Aug 9, 2013Estimated

Name	Class
Oridion	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Early Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Device interface comfort assessment	Other	Single group rates one noninvasive respiratory monitoring interface and then another.	Device: Respiratory monitor patient interface.

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Respiratory monitor patient interface.	Device	Wear each interface for 20 minutes	Device interface comfort assessment

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Comfort Rating Self-Report Instrument	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).	5 Minutes

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

49 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jonathan B Waugh, PhD	University of Alabama at Birmingham	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Alabama at Birmingham		Birmingham	Alabama	35294-1212	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
	Result	Waugh JB, Epps CA. Comfort evaluation of noninvasive respiratory monitoring interfaces. Respir Care 2011; 56(10): 1722.