Comfort Check of CO2 Monitoring Cannulas With Oxygen Delivery

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Medtronic

Status

Completed

Conditions

Wearing Comfort

Treatments

Device: Oridion Smart CapnoLine® Plus with Non-Wedge cannula
Device: Experimental sample line Model 3
Device: Experimental sample line Model 4
Device: Oridion Smart CapnoLine® H Plus with Wedge cannula
Device: Experimental sample line Model 5
Device: O2/CO2 cannula w/female luer (Westmed comfort plus #0504)

Study type

Interventional

Funder types

Industry

Identifiers

NCT03109132
MDT17070

Details and patient eligibility

About

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.

Full 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.

Enrollment

60 patients

Sex

All

Ages

50 to 85 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Device Feasibility

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Triple Blind

60 participants in 6 patient groups

Model 1
Active Comparator group
Description:
Device - O2/CO2 Oral/Nasal cannula sample line - Oridion smart CapnoLine® H Plus with Wedge cannula
Treatment:
Device: Oridion Smart CapnoLine® H Plus with Wedge cannula
Model 2
Active Comparator group
Description:
Device -O2/CO2 Oral/Nasal cannula sample line- Oridion smart CapnoLine® Plus with Non-Wedge cannula
Treatment:
Device: Oridion Smart CapnoLine® Plus with Non-Wedge cannula
Model 3
Active Comparator group
Description:
Device - Experimental sample line Model 3
Treatment:
Device: Experimental sample line Model 3
Model 4
Active Comparator group
Description:
Device - Experimental sample line Model 4
Treatment:
Device: Experimental sample line Model 4
Model 5
Active Comparator group
Description:
Device - Experimental sample line Model 5
Treatment:
Device: Experimental sample line Model 5
Model 6
Active Comparator group
Description:
Device - O2/CO2 cannula w/female luer (Westmed comfort plus #0504)
Treatment:
Device: O2/CO2 cannula w/female luer (Westmed comfort plus #0504)

Trial contacts and locations

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Data sourced from clinicaltrials.gov

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