Comfort Check of CO2 Monitoring Cannulas With Oxygen Delivery

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.

Study Overview

• Status: Completed
• Conditions: Wearing Comfort
• Intervention / Treatment: Device: Oridion Smart CapnoLine® H Plus with Wedge cannula; Device: Oridion Smart CapnoLine® Plus with Non-Wedge cannula; Device: Experimental sample line Model 3; Device: Experimental sample line Model 4; Device: Experimental sample line Model 5; Device: O2/CO2 cannula w/female luer (Westmed comfort plus #0504)

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.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Israel
  • Tel Aviv, Israel, 62917
    • The Israeli Institute for skin reaserch

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 85 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: DEVICE_FEASIBILITY
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: TRIPLE

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Model 1; Device - O2/CO2 Oral/Nasal cannula sample line - Oridion smart CapnoLine® H Plus with Wedge cannula	Device: Oridion Smart CapnoLine® H Plus with Wedge cannula; The subjects will assess the comfort level of the different cannulas; Other Names: Usability test for arm 1
ACTIVE_COMPARATOR: Model 2; Device -O2/CO2 Oral/Nasal cannula sample line- Oridion smart CapnoLine® Plus with Non-Wedge cannula	Device: Oridion Smart CapnoLine® Plus with Non-Wedge cannula; The subjects will assess the comfort level of the different cannulas; Other Names: Usability test for arm 2
ACTIVE_COMPARATOR: Model 3; Device - Experimental sample line Model 3	Device: Experimental sample line Model 3; The subjects will assess the comfort level of the different cannulas; Other Names: Usability test for arm 3
ACTIVE_COMPARATOR: Model 4; Device - Experimental sample line Model 4	Device: Experimental sample line Model 4; The subjects will assess the comfort level of the different cannulas; Other Names: Usability test for arm 4
ACTIVE_COMPARATOR: Model 5; Device - Experimental sample line Model 5	Device: Experimental sample line Model 5; The subjects will assess the comfort level of the different cannulas; Other Names: Usability test for arm 5
ACTIVE_COMPARATOR: Model 6; Device - O2/CO2 cannula w/female luer (Westmed comfort plus #0504)	Device: O2/CO2 cannula w/female luer (Westmed comfort plus #0504); The subjects will assess the comfort level of the different cannulas; Other Names: Usability test for arm 6

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Medtronic - MITG
• Collaborators: Institute for Skin Research, Israel
• Investigators: Principal Investigator: Sarah Brenner, Prof., The Israeli Institute for Skin Research

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 23, 2017
• Primary Completion (ACTUAL): August 30, 2017
• Study Completion (ACTUAL): August 30, 2017

Study Registration Dates

• First Submitted: January 26, 2017
• First Submitted That Met QC Criteria: April 5, 2017
• First Posted (ACTUAL): April 12, 2017

Study Record Updates

• Last Update Posted (ACTUAL): December 8, 2017
• Last Update Submitted That Met QC Criteria: December 6, 2017
• Last Verified: December 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: MDT17070

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No