Comfort Check of CO2 Monitoring Cannulas With Oxygen Delivery

Medtronic - MITG60 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

DEVICE_FEASIBILITY

Masking

TRIPLE

Enrollment

Conditions

Wearing Comfort

Interventions

Oridion Smart CapnoLine® H Plus with Wedge cannulaDEVICE

The subjects will assess the comfort level of the different cannulas

Oridion Smart CapnoLine® Plus with Non-Wedge cannulaDEVICE

The subjects will assess the comfort level of the different cannulas

Experimental sample line Model 3DEVICE

The subjects will assess the comfort level of the different cannulas

Eligibility

Sex: ALLMin age: 50 YearsMax age: 85 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

The Israeli Institute for skin reaserch

Tel Aviv, Israel

Outcomes

Primary Outcomes

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

Time frame: 3 months

Secondary Outcomes

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.

Time frame: 3 months

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.