Comfort Check of CO2 Monitoring Cannulas With Oxygen Delivery

Medtronic

Status: Completed

Conditions: Wearing Comfort

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT03109132

MDT17070

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 50 to 85 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Device Feasibility

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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60 participants in 6 patient groups

Model 1

Active Comparator group

Description:

Device - O2/CO2 Oral/Nasal cannula sample line - Oridion smart CapnoLine® H Plus with Wedge cannula

Treatment:

Device: Oridion Smart CapnoLine® H Plus with Wedge cannula

Model 2

Active Comparator group

Description:

Device -O2/CO2 Oral/Nasal cannula sample line- Oridion smart CapnoLine® Plus with Non-Wedge cannula

Treatment:

Device: Oridion Smart CapnoLine® Plus with Non-Wedge cannula

Model 3

Active Comparator group

Description:

Device - Experimental sample line Model 3

Treatment:

Device: Experimental sample line Model 3

Model 4

Active Comparator group

Description:

Device - Experimental sample line Model 4

Treatment:

Device: Experimental sample line Model 4

Model 5

Active Comparator group

Description:

Device - Experimental sample line Model 5

Treatment:

Device: Experimental sample line Model 5

Model 6

Active Comparator group

Description:

Device - O2/CO2 cannula w/female luer (Westmed comfort plus #0504)

Treatment:

Device: O2/CO2 cannula w/female luer (Westmed comfort plus #0504)