Effect of Non-Invasive Ventilation in Cystic Fibrosis Patient With Chronic Respiratory Failure.
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|ClinicalTrials.gov Identifier: NCT00208078|
Recruitment Status : Terminated (Not enough patient recruited)
First Posted : September 21, 2005
Last Update Posted : February 13, 2013
|Condition or disease||Intervention/treatment||Phase|
|Cystic Fibrosis Chronic Respiratory Failure||Device: pressure support ventilator||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||36 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Evaluation of the Effects of Long Term Non-Invasive Ventilation in Patient With Cystic Fibrosis and Chronic Hypercapnic Respiratory Failure.|
|Study Start Date :||May 2005|
|Actual Primary Completion Date :||May 2010|
|Actual Study Completion Date :||May 2011|
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 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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)|