Wearing Comfort
Conditions
Brief 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 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.
Interventions
DEVICEOridion Smart CapnoLine® H Plus with Wedge cannula
The subjects will assess the comfort level of the different cannulas
DEVICEOridion Smart CapnoLine® Plus with Non-Wedge cannula
The subjects will assess the comfort level of the different cannulas
DEVICEExperimental sample line Model 3
The subjects will assess the comfort level of the different cannulas
DEVICEExperimental sample line Model 4
The subjects will assess the comfort level of the different cannulas
DEVICEExperimental sample line Model 5
The subjects will assess the comfort level of the different cannulas
DEVICEO2/CO2 cannula w/female luer (Westmed comfort plus #0504)
The subjects will assess the comfort level of the different cannulas
Sponsors
Institute for Skin Research, Israel
Medtronic - MITG
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
DEVICE_FEASIBILITY
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Masking description
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.
Intervention model description
This is randomnized crossover study. Every subject will assess all cannulas in randomized order.
Eligibility
Sex/Gender
ALL
Age
50 Years to 85 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Comfort evaluation using self introduction questionnaire | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Comfort evaluation using self introduction questionnaire - calculations | 3 months | 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. |
Countries
Israel
Outcome results
None listed