Ignite Creation Date:
2025-12-24 @ 9:58 PM
Ignite Modification Date:
2026-07-06 @ 2:05 AM
Study NCT ID:
NCT03809832
Status:
TERMINATED
Last Update Posted:
2019-09-04
First Post:
2019-01-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Microbiologic Contamination of Home Non Invasive Ventilators
Sponsor:
University Hospital, Rouen
Organization:
Study Overview
Official Title:
Microbiologic Contamination of Home Non Invasive Ventilators
Status:
TERMINATED
Status Verified Date:
2019-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Preliminary results providing sufficient data
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MiCONIV
Brief Summary:
Home non-invasive ventilators are daily used by patients with chronic respiratory failure. There are frequently used with warming and humidifying systems. These systems need to be cared for and frequently washed by the patient.
The aim of this study is to evaluate if the humidifying system of home ventilators are colonized by microbiological germs.
The aim of this study is to evaluate if the humidifying system of home ventilators are colonized by microbiological germs.
Detailed Description:
The use of non-invasive ventilators is common for treating respiratory failure. Their care relies on the patients and their carers.
No study has assessed the efficacy of such care with respect to the number of microbiological specimens that remain in the humidifier.
No study has assessed the efficacy of such care with respect to the number of microbiological specimens that remain in the humidifier.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: