Comfort Check of CO2 Monitoring Cannulas With Oxygen Delivery

Study Overview
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Brief Summary
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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
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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.

Official Title
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Comfort Check of CO2 Monitoring Cannulas With Oxygen Delivery

Conditions
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Wearing Comfort

Intervention / Treatment
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* Device: Oridion Smart CapnoLine® H Plus with Wedge cannula
* Device: Oridion Smart CapnoLine® Plus with Non-Wedge cannula
* Device: Experimental sample line Model 3
* Device: Experimental sample line Model 4
* Device: Experimental sample line Model 5
* Device: O2/CO2 cannula w/female luer (Westmed comfort plus #0504)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy Volunteers Men and Women Age 50-85 Willingness to participate in the study Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Device Feasibility
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: This is randomnized crossover study. Every subject will assess all cannulas in randomized order.
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Model 1<br>Device - O2/CO2 Oral/Nasal cannula sample line - Oridion smart CapnoLine® H Plus with Wedge cannula | Device: Oridion Smart CapnoLine® H Plus with Wedge cannula<br>* The subjects will assess the comfort level of the different cannulas<br>* Other names: Usability test for arm 1;|
| Active Comparator: Model 2<br>Device -O2/CO2 Oral/Nasal cannula sample line- Oridion smart CapnoLine® Plus with Non-Wedge cannula | Device: Oridion Smart CapnoLine® Plus with Non-Wedge cannula<br>* The subjects will assess the comfort level of the different cannulas<br>* Other names: Usability test for arm 2;|
| Active Comparator: Model 3<br>Device - Experimental sample line Model 3 | Device: Experimental sample line Model 3<br>* The subjects will assess the comfort level of the different cannulas<br>* Other names: Usability test for arm 3;|
| Active Comparator: Model 4<br>Device - Experimental sample line Model 4 | Device: Experimental sample line Model 4<br>* The subjects will assess the comfort level of the different cannulas<br>* Other names: Usability test for arm 4;|
| Active Comparator: Model 5<br>Device - Experimental sample line Model 5 | Device: Experimental sample line Model 5<br>* The subjects will assess the comfort level of the different cannulas<br>* Other names: Usability test for arm 5;|
| Active Comparator: Model 6<br>Device - O2/CO2 cannula w/female luer (Westmed comfort plus #0504) | Device: O2/CO2 cannula w/female luer (Westmed comfort plus #0504)<br>* The subjects will assess the comfort level of the different cannulas<br>* Other names: Usability test for arm 6;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 3 months |