NCT03109132

Comfort Check of CO2 Monitoring Cannulas With Oxygen Delivery

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Medtronic - MITG · Industry
• Sex: All
• Age: 50 Years – 85 Years
• Healthy volunteers: Accepted

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.

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.

Conditions

• Wearing Comfort

Interventions

Type	Name	Description
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

Timeline

• Start date: 2017-04-23
• Primary completion: 2017-08-30
• Completion: 2017-08-30
• First posted: 2017-04-12
• Last updated: 2017-12-08

Locations

1 site across 1 country: Israel