Ignite Creation Date:
2024-05-05 @ 11:59 AM
Last Modification Date:
2024-10-26 @ 9:18 AM
Study NCT ID:
NCT00208078
Status:
TERMINATED
Last Update Posted:
2013-02-13
First Post:
2005-09-13
Brief Title:
Effect of Non-Invasive Ventilation in Cystic Fibrosis Patient With Chronic Respiratory Failure
Sponsor:
Cochin Hospital
Organization:
Cochin Hospital India
Study Overview
Official Title:
Evaluation of the Effects of Long Term Non-Invasive Ventilation in Patient With Cystic Fibrosis and Chronic Hypercapnic Respiratory Failure
Status:
TERMINATED
Status Verified Date:
2013-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not enough patient recruited
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
There is no randomised controlled trials to determine the clinical effects of long term Non-Invasive Ventilation in Cystic Fibrosis patients
Detailed Description:
The effects of long term mechanical ventilation for the treatment of respiratory failure in patients with neuromuscular diseases is well established
Long term non-invasive ventilation is commonly used in the treatment of Cystic Fibrosis patients with respiratory failure However the benefits of this treatment have never been studied in randomized control trials and are unknown
The goal of this multicenter study is to evaluate the effects of the addition of non-invasive ventilation to the standard therapy in stable Cystic Fibrosis patients with chronic hypercapnia
Two groups of patients will be followed The first group will receive standard treatment for advanced Cystic Fibrosis according to international guidelines the second group will receive the same treatment plus non-invasive ventilation 4Hday The follow up time will be one year for each patient
Long term non-invasive ventilation is commonly used in the treatment of Cystic Fibrosis patients with respiratory failure However the benefits of this treatment have never been studied in randomized control trials and are unknown
The goal of this multicenter study is to evaluate the effects of the addition of non-invasive ventilation to the standard therapy in stable Cystic Fibrosis patients with chronic hypercapnia
Two groups of patients will be followed The first group will receive standard treatment for advanced Cystic Fibrosis according to international guidelines the second group will receive the same treatment plus non-invasive ventilation 4Hday The follow up time will be one year for each patient
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None