Comfort Check of CO2 Monitoring Cannulas With Oxygen Delivery

Wearing Comfort Clinical Trial

Official title:

Comfort Check of CO2 Monitoring Cannulas With Oxygen Delivery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03109132
• Other study ID #: MDT17070
• Status: Completed
• Phase: N/A
• First received: January 26, 2017
• Last updated: December 6, 2017
• Start date: April 23, 2017
• Est. completion date: August 30, 2017

Study information

• Verified date: December 2017
• Source: Medtronic - MITG
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: August 30, 2017
• Est. primary completion date: August 30, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Wearing Comfort

Intervention

Device:
• Oridion Smart CapnoLine® H Plus with Wedge cannula
The subjects will assess the comfort level of the different cannulas
• Oridion Smart CapnoLine® Plus with Non-Wedge cannula
The subjects will assess the comfort level of the different cannulas
• Experimental sample line Model 3
The subjects will assess the comfort level of the different cannulas
• Experimental sample line Model 4
The subjects will assess the comfort level of the different cannulas
• Experimental sample line Model 5
The subjects will assess the comfort level of the different cannulas
• O2/CO2 cannula w/female luer (Westmed comfort plus #0504)
The subjects will assess the comfort level of the different cannulas

Locations

Country	Name	City	State
Israel	The Israeli Institute for skin reaserch	Tel Aviv

Sponsors (2)

Lead Sponsor	Collaborator
Medtronic - MITG	Institute for Skin Research, Israel

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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