Ignite Creation Date:
2025-12-24 @ 9:46 PM
Ignite Modification Date:
2026-01-01 @ 2:46 AM
Study NCT ID:
NCT03109132
Status:
COMPLETED
Last Update Posted:
2017-12-08
First Post:
2017-01-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comfort Check of CO2 Monitoring Cannulas With Oxygen Delivery
Sponsor:
Medtronic - MITG
Organization:
Study Overview
Official Title:
Comfort Check of CO2 Monitoring Cannulas With Oxygen Delivery
Status:
COMPLETED
Status Verified Date:
2017-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: