Effect of Non-Invasive Ventilation in Cystic Fibrosis Patient With Chronic Respiratory Failure.
|Cystic Fibrosis Chronic Respiratory Failure||Device: pressure support ventilator||Phase 4|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Evaluation of the Effects of Long Term Non-Invasive Ventilation in Patient With Cystic Fibrosis and Chronic Hypercapnic Respiratory Failure.|
- The effect of non-invasive ventilation on room air PaCO2 at one year: Hypothesis is PaCO2 stabilisation in the non-invasive ventilation group compared to a increase in PaCO2 in the control group (standard treatment) [ Time Frame: ended 2011 ]
- Effects of non-invasive ventilation on dyspnea index, functional status (6 minutes walking test, spirometric values), pulmonary exacerbations and body mass index (BMI) compared to standard treatment. [ Time Frame: ended 2011 ]
|Study Start Date:||May 2005|
|Study Completion Date:||May 2011|
|Primary Completion Date:||May 2010 (Final data collection date for primary outcome measure)|
No Intervention: Usual medical therapy
Usual CF care
Experimental: Non-invasive ventilation
Pressure support ventilator (SAIME,AIROX)
Device: pressure support ventilator
Non invasive ventilation 4h/d 5 days a week
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 (4H/day). The follow up time will be one year for each patient.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00208078
|Department of pulmonary disease of Cochin Hospital (AP-HP)|
|Paris, France, 75679|
|Principal Investigator:||Pierre-Régis Burgel||Department of pulmonary disease of Cochin Hospital (AP-HP)|