Comfort Check of CO2 Monitoring Cannulas With Oxygen Delivery

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.

Conditions

• Wearing Comfort

Interventions

DEVICE

Oridion Smart CapnoLine® H Plus with Wedge cannula

The subjects will assess the comfort level of the different cannulas

DEVICE

Oridion Smart CapnoLine® Plus with Non-Wedge cannula

The subjects will assess the comfort level of the different cannulas

DEVICE

Experimental sample line Model 3

The subjects will assess the comfort level of the different cannulas

DEVICE

Experimental sample line Model 4

The subjects will assess the comfort level of the different cannulas

DEVICE

Experimental sample line Model 5

The subjects will assess the comfort level of the different cannulas

DEVICE

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

The subjects will assess the comfort level of the different cannulas

Sponsors & Collaborators

• Institute for Skin Research, Israel

  collaborator INDUSTRY

• Medtronic - MITG

  lead INDUSTRY

Principal Investigators

• Sarah Brenner, Prof. · The Israeli Institute for Skin Research

Study Design

Allocation

RANDOMIZED

Purpose

DEVICE_FEASIBILITY

Masking

TRIPLE

Model

CROSSOVER

Eligibility

Min Age

50 Years

Max Age

85 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2017-04-23

Primary Completion

2017-08-30

Completion

2017-08-30

Countries

• Israel

Study Locations