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| Name | Class |
|---|---|
| Institute for Skin Research, Israel | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Model 1 | Active Comparator | Device - O2/CO2 Oral/Nasal cannula sample line - Oridion smart CapnoLine® H Plus with Wedge cannula |
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| Model 2 | Active Comparator | Device -O2/CO2 Oral/Nasal cannula sample line- Oridion smart CapnoLine® Plus with Non-Wedge cannula |
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| Model 3 | Active Comparator | Device - Experimental sample line Model 3 |
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| Model 4 | Active Comparator | Device - Experimental sample line Model 4 |
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| Model 5 | Active Comparator | Device - Experimental sample line Model 5 |
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| Model 6 | Active Comparator |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oridion Smart CapnoLine® H Plus with Wedge cannula | Device | The subjects will assess the comfort level of the different cannulas |
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| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sarah Brenner, Prof. | The Israeli Institute for Skin Research | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Israeli Institute for skin reaserch | Tel Aviv | 62917 | Israel |
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This is randomnized crossover study. Every subject will assess all cannulas in randomized order.
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This is a double-blind, order randomized study. All cannulas will be numbered. The investigators, the outcomes assessors and the subjects will be blind to the identity of the cannulas. The order of which the subjects will assess the cannulas will be randomized.
Device - O2/CO2 cannula w/female luer (Westmed comfort plus #0504)
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| Oridion Smart CapnoLine® Plus with Non-Wedge cannula | Device | The subjects will assess the comfort level of the different cannulas |
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| Experimental sample line Model 3 | Device | The subjects will assess the comfort level of the different cannulas |
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| Experimental sample line Model 4 | Device | The subjects will assess the comfort level of the different cannulas |
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| Experimental sample line Model 5 | Device | The subjects will assess the comfort level of the different cannulas |
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| O2/CO2 cannula w/female luer (Westmed comfort plus #0504) | Device | The subjects will assess the comfort level of the different cannulas |
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