Respiratory Device ComfortEarly Phase 1NCT01494844
Comfort Evaluation of Non-Invasive Respiratory Monitor Interfaces
A Early Phase 1 study testing Respiratory monitor patient interface. in people with Respiratory Device Comfort, run by University of Alabama at Birmingham at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 49 yearsHealthy volunteers can take part
- Conditions the study is for
- Respiratory Device Comfort
- What is being tested?
- Respiratory monitor patient interface.
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2011to Sep 2011
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 49 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- Any injury or condition that would affect assessment of comfort.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Alabama at Birmingham
Birmingham, Alabama, 35294-1212
About this study
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
- Being tested
- Respiratory monitor patient interface.
- Keywords
- Patient Monitoring, Capnography, Human Engineering
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Respiratory monitor patient interface.Device
Also called Masimo Rainbow Acoustic Monitoring sensor, Oridion Smart Capnoline Plus H sensor
Wear each interface for 20 minutes
| Study group | Role | What they receive |
|---|---|---|
| Device interface comfort assessment | Other | Single group rates one noninvasive respiratory monitoring interface and then another. Receives: Device: Respiratory monitor patient interface. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 5 Minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2011 (estimated)
- Study startJun 2011
- Primary completionSep 2011
- Study completionSep 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Respiratory Device ComfortStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- Oridion
- Responsible party
- Principal investigator, Jonathan B. Waugh, PhD, University of Alabama at Birmingham
- Investigators
- Jonathan B Waugh, PhD, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01494844
- Sponsor's protocol ID
- X110421003
- Other IDs
- 413525
- Status last verified
- Aug 2013
- First submitted
- 15 Dec 2011
- Last updated
- 9 Aug 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Waugh JB, Epps CA. Comfort evaluation of noninvasive respiratory monitoring interfaces. Respir Care 2011; 56(10): 1722.
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comfort Evaluation of Non-Invasive Respiratory Monitor Interfaces
- ClinicalTrials.gov ID
- NCT01494844
- Acronym / sponsor ID
- X110421003
- Conditions
- Respiratory Device Comfort
- Keywords
- Patient Monitoring, Capnography, Human Engineering
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Collaborators
- Oridion
- Study start
- Jun 2011
- Primary completion
- Sep 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 19 Dec 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Device interface comfort assessment | Other | Device: Respiratory monitor patient interface.Single group rates one noninvasive respiratory monitoring interface and then another. |
Who may qualify
- Ages
- 20 to 49 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (1 listed)
- Any injury or condition that would affect assessment of comfort.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Respiratory monitor patient interface.Also: Masimo Rainbow Acoustic Monitoring sensor, Oridion Smart Capnoline Plus H sensorWear each interface for 20 minutes | Device | Device interface comfort assessment |
Primary outcome
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2013.
- Results publicationWaugh JB, Epps CA. Comfort evaluation of noninvasive respiratory monitoring interfaces. Respir Care 2011; 56(10): 1722.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jonathan B Waugh, PhD principal investigator
University of Alabama at Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Respiratory monitor patient interface. in people with Respiratory Device Comfort, run by University of Alabama at Birmingham at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comfort Rating Self-Report Instrument (time frame: 5 Minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01494844, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2013.