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NCT03109132

Comfort Check of CO2 Monitoring Cannulas With Oxygen Delivery

NCT ID: NCT03109132

Last Updated: 2017-12-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-04-23

Study Completion Date

2017-08-30

Brief Summary

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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

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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.

Conditions

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Wearing Comfort

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

This is randomnized crossover study. Every subject will assess all cannulas in randomized order.

Primary Study Purpose

DEVICE_FEASIBILITY

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

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.

Study Groups

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Model 1

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

Group Type ACTIVE_COMPARATOR

Oridion Smart CapnoLine® H Plus with Wedge cannula

Intervention Type DEVICE

The subjects will assess the comfort level of the different cannulas

Model 2

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

Group Type ACTIVE_COMPARATOR

Oridion Smart CapnoLine® Plus with Non-Wedge cannula

Intervention Type DEVICE

The subjects will assess the comfort level of the different cannulas

Model 3

Device - Experimental sample line Model 3

Group Type ACTIVE_COMPARATOR

Experimental sample line Model 3

Intervention Type DEVICE

The subjects will assess the comfort level of the different cannulas

Model 4

Device - Experimental sample line Model 4

Group Type ACTIVE_COMPARATOR

Experimental sample line Model 4

Intervention Type DEVICE

The subjects will assess the comfort level of the different cannulas

Model 5

Device - Experimental sample line Model 5

Group Type ACTIVE_COMPARATOR

Experimental sample line Model 5

Intervention Type DEVICE

The subjects will assess the comfort level of the different cannulas

Model 6

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

Group Type ACTIVE_COMPARATOR

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

Intervention Type DEVICE

The subjects will assess the comfort level of the different cannulas

Interventions

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Oridion Smart CapnoLine® H Plus with Wedge cannula

The subjects will assess the comfort level of the different cannulas

Intervention Type DEVICE

Oridion Smart CapnoLine® Plus with Non-Wedge cannula

The subjects will assess the comfort level of the different cannulas

Intervention Type DEVICE

Experimental sample line Model 3

The subjects will assess the comfort level of the different cannulas

Intervention Type DEVICE

Experimental sample line Model 4

The subjects will assess the comfort level of the different cannulas

Intervention Type DEVICE

Experimental sample line Model 5

The subjects will assess the comfort level of the different cannulas

Intervention Type DEVICE

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

The subjects will assess the comfort level of the different cannulas

Intervention Type DEVICE

Other Intervention Names

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Usability test for arm 1 Usability test for arm 2 Usability test for arm 3 Usability test for arm 4 Usability test for arm 5 Usability test for arm 6

Eligibility Criteria

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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

Minimum Eligible Age

50 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Institute for Skin Research, Israel

INDUSTRY

Sponsor Role collaborator

Medtronic - MITG

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sarah Brenner, Prof.

Role: PRINCIPAL_INVESTIGATOR

The Israeli Institute for Skin Research

Locations

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The Israeli Institute for skin reaserch

Tel Aviv, , Israel

Site Status

Countries

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Israel

Other Identifiers

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MDT17070

Identifier Type: -

Identifier Source: org_study_id