Wearing ComfortNCT03109132
Comfort Check of CO2 Monitoring Cannulas With Oxygen Delivery
A study testing Oridion Smart CapnoLine® H Plus with Wedge cannula, Oridion Smart CapnoLine® Plus with Non-Wedge cannula and Experimental sample line Model 3 in people with Wearing Comfort, run by Medtronic - MITG at 1 site in Israel.
Trial summary
The purpose of this test is to evaluate the comfort level of several model configurations of the Smart CapnoLine plus cannula The test focuses on the comfort / discomfort generated by the device, mainly due to tubes around the ears and on the face skin, the cannula itself (especially in the nostrils and the mouth… Read more about this study
- Who is it for?
- Ages 50 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Wearing Comfort
- What is being tested?
- Oridion Smart CapnoLine® H Plus with Wedge cannula, Oridion Smart CapnoLine® Plus with Non-Wedge cannula and Experimental sample line Model 3
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteIsrael
- Study dates
- 23 Apr 2017to 30 Aug 2017
- Phase
- Interventional
- 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 50 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy Volunteers
- Men and Women
- Age 50-85
- Willingness to participate in the study
Who cannot join
- Women who are pregnant or breastfeeding
- Subjects with sensitivity to any of the products or the its ingredient
- Subjects with sensitivity to preparation for testing bacterial plaque
- Subjects who are treated with anti inflammatory antihistamine corticosteroids treatment
- Subjects who are treated with Anti-thrombotic agents
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this test is to evaluate the comfort level of several model configurations of the Smart CapnoLine plus cannula The test focuses on the comfort / discomfort generated by the device, mainly due to tubes around the ears and on the face skin, the cannula itself (especially in the nostrils and the mouth surrounding) and the smell.
Read the detailed description
This test compares 4 models for the duration of up to 3 days each and 2 models with duration of up to 24 hours. Each subject will tested the models and will provide feedback at predefined times during the test. During the test and according to initial result the team may decide to shorten the test duration.
The testing staff will include a dermatologist and a technical representative that will supervise the test in order to monitor and control the required performance of the subjects according to test protocol, and relevant outcomes. During the test the dermatologist will monitor any unexpected skin reaction or patient discomfort.
- Conditions
- Wearing Comfort
- Being tested
- Oridion Smart CapnoLine® H Plus with Wedge cannula, Oridion Smart CapnoLine® Plus with Non-Wedge cannula, Experimental sample line Model 3, Experimental sample line Model 4, Experimental sample line Model 5
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oridion Smart CapnoLine® H Plus with Wedge cannulaDevice
Also called Usability test for arm 1
The subjects will assess the comfort level of the different cannulas
Oridion Smart CapnoLine® Plus with Non-Wedge cannulaDevice
Also called Usability test for arm 2
The subjects will assess the comfort level of the different cannulas
Experimental sample line Model 3Device
Also called Usability test for arm 3
The subjects will assess the comfort level of the different cannulas
Experimental sample line Model 4Device
Also called Usability test for arm 4
The subjects will assess the comfort level of the different cannulas
Experimental sample line Model 5Device
Also called Usability test for arm 5
The subjects will assess the comfort level of the different cannulas
O2/CO2 cannula w/female luer (Westmed comfort plus #0504)Device
Also called Usability test for arm 6
The subjects will assess the comfort level of the different cannulas
| Study group | Role | What they receive |
|---|---|---|
| Model 1 | Active comparator | Device - O2/CO2 Oral/Nasal cannula sample line - Oridion smart CapnoLine® H Plus with Wedge cannula Receives: Device: Oridion Smart CapnoLine® H Plus with Wedge cannula |
| Model 2 | Active comparator | Device -O2/CO2 Oral/Nasal cannula sample line- Oridion smart CapnoLine® Plus with Non-Wedge cannula Receives: Device: Oridion Smart CapnoLine® Plus with Non-Wedge cannula |
| Model 3 | Active comparator | Device - Experimental sample line Model 3 Receives: Device: Experimental sample line Model 3 |
| Model 4 | Active comparator | Device - Experimental sample line Model 4 Receives: Device: Experimental sample line Model 4 |
| Model 5 | Active comparator | Device - Experimental sample line Model 5 Receives: Device: Experimental sample line Model 5 |
| Model 6 | Active comparator | Device - O2/CO2 cannula w/female luer (Westmed comfort plus #0504) Receives: Device: O2/CO2 cannula w/female luer (Westmed comfort plus #0504) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comfort evaluation using self introduction questionnaire
Measuring comfort on a scale of 1 -7, where 1 = not comfortable, 7 = very comfortable Data will be reported using self introduction questionnaires in different time intervals
Measured: 3 months
Secondary outcomes (1)
Comfort evaluation using self introduction questionnaire - calculations
The average comfort will be calculated for each time interval and for the all period. The values has no units, this is a subjective evaluation and not clinical value measured.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2017
- Study start23 Apr 2017
- Primary completion30 Aug 2017
- Study completion30 Aug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Wearing ComfortStudies of the same condition, open and under way.
- 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
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- This is randomnized crossover study. Every subject will assess all cannulas in randomized order.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic - MITG
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Institute for Skin Research, Israel
- Responsible party
- Sponsor
- Investigators
- Sarah Brenner, Prof., Principal investigator, The Israeli Institute for Skin Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03109132
- Sponsor's protocol ID
- MDT17070
- Status last verified
- Dec 2017
- First submitted
- 26 Jan 2017
- Last updated
- 8 Dec 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comfort Check of CO2 Monitoring Cannulas With Oxygen Delivery
- ClinicalTrials.gov ID
- NCT03109132
- Acronym / sponsor ID
- MDT17070
- Conditions
- Wearing Comfort
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Medtronic - MITGIndustry (pharma, biotech, devices)
- Collaborators
- Institute for Skin Research, Israel
- Study start
- 23 Apr 2017 (actual)
- Primary completion
- 30 Aug 2017 (actual)
- Study completion
- 30 Aug 2017 (actual)
- First posted
- 12 Apr 2017 (actual)
- 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.
The purpose of this test is to evaluate the comfort level of several model configurations of the Smart CapnoLine plus cannula The test focuses on the comfort / discomfort generated by the device, mainly due to tubes around the ears and on the face skin, the cannula itself (especially in the nostrils and the mouth surrounding) and the smell.
Detailed description
This test compares 4 models for the duration of up to 3 days each and 2 models with duration of up to 24 hours. Each subject will tested the models and will provide feedback at predefined times during the test. During the test and according to initial result the team may decide to shorten the test duration.
The testing staff will include a dermatologist and a technical representative that will supervise the test in order to monitor and control the required performance of the subjects according to test protocol, and relevant outcomes. During the test the dermatologist will monitor any unexpected skin reaction or patient discomfort.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 6
- Model description
- This is randomnized crossover study. Every subject will assess all cannulas in randomized order.
| Arm | Type | Receives |
|---|---|---|
| Model 1 | Active comparator | Device: Oridion Smart CapnoLine® H Plus with Wedge cannulaDevice - O2/CO2 Oral/Nasal cannula sample line - Oridion smart CapnoLine® H Plus with Wedge cannula |
| Model 2 | Active comparator | Device: Oridion Smart CapnoLine® Plus with Non-Wedge cannulaDevice -O2/CO2 Oral/Nasal cannula sample line- Oridion smart CapnoLine® Plus with Non-Wedge cannula |
| Model 3 | Active comparator | Device: Experimental sample line Model 3Device - Experimental sample line Model 3 |
| Model 4 | Active comparator | Device: Experimental sample line Model 4Device - Experimental sample line Model 4 |
| Model 5 | Active comparator | Device: Experimental sample line Model 5Device - Experimental sample line Model 5 |
| Model 6 | Active comparator | Device: O2/CO2 cannula w/female luer (Westmed comfort plus #0504)Device - O2/CO2 cannula w/female luer (Westmed comfort plus #0504) |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Healthy Volunteers
- Men and Women
- Age 50-85
- Willingness to participate in the study
Key exclusion criteria (5 listed)
- Women who are pregnant or breastfeeding
- Subjects with sensitivity to any of the products or the its ingredient
- Subjects with sensitivity to preparation for testing bacterial plaque
- Subjects who are treated with anti inflammatory antihistamine corticosteroids treatment
- Subjects who are treated with Anti-thrombotic agents
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 |
|---|---|---|
| Oridion Smart CapnoLine® H Plus with Wedge cannulaAlso: Usability test for arm 1The subjects will assess the comfort level of the different cannulas | Device | Model 1 |
| Oridion Smart CapnoLine® Plus with Non-Wedge cannulaAlso: Usability test for arm 2The subjects will assess the comfort level of the different cannulas | Device | Model 2 |
| Experimental sample line Model 3Also: Usability test for arm 3The subjects will assess the comfort level of the different cannulas | Device | Model 3 |
| Experimental sample line Model 4Also: Usability test for arm 4The subjects will assess the comfort level of the different cannulas | Device | Model 4 |
| Experimental sample line Model 5Also: Usability test for arm 5The subjects will assess the comfort level of the different cannulas | Device | Model 5 |
| O2/CO2 cannula w/female luer (Westmed comfort plus #0504)Also: Usability test for arm 6The subjects will assess the comfort level of the different cannulas | Device | Model 6 |
Primary outcome
Comfort evaluation using self introduction questionnaire
Time frame: 3 months
Measuring comfort on a scale of 1 -7, where 1 = not comfortable, 7 = very comfortable Data will be reported using self introduction questionnaires in different time intervals
1 secondary outcome
Comfort evaluation using self introduction questionnaire - calculations
Time frame: 3 months
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 8 Dec 2017.
- Individual participant dataSharing planned: No
Related trials for Wearing Comfort
Recruiting
An Evaluation of Myopia Control Lenses on Wearing Experience in Myopic Children
Myopia, Refractive Error
Enrolling by invitation
Differences and Wearing Safety and Comfort of New Defocus Incorporated Multiple Segments Spectacle Lenses
Myopia, Progressive
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.
Sarah Brenner, Prof. principal investigator
The Israeli Institute for Skin Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oridion Smart CapnoLine® H Plus with Wedge cannula, Oridion Smart CapnoLine® Plus with Non-Wedge cannula and Experimental sample line Model 3 in people with Wearing Comfort, run by Medtronic - MITG at 1 site in Israel.
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 4 inclusion and 5 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 8 Dec 2017. 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 Israel. 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.
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 evaluation using self introduction questionnaire (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Dec 2017.