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There is no randomised controlled trials to determine the clinical effects of long term Non-Invasive Ventilation in Cystic Fibrosis patients.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Usual medical therapy | No Intervention | Usual CF care | |
| Non-invasive ventilation | Experimental | Pressure support ventilator (SAIME,AIROX) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| pressure support ventilator | Device | Non invasive ventilation 4h/d 5 days a week |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) | ended 2011 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | ended 2011 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pierre-Régis Burgel | Department of pulmonary disease of Cochin Hospital (AP-HP) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of pulmonary disease of Cochin Hospital (AP-HP) | Paris | 75679 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15502116 | Background | Ellaffi M, Vinsonneau C, Coste J, Hubert D, Burgel PR, Dhainaut JF, Dusser D. One-year outcome after severe pulmonary exacerbation in adults with cystic fibrosis. Am J Respir Crit Care Med. 2005 Jan 15;171(2):158-64. doi: 10.1164/rccm.200405-667OC. Epub 2004 Oct 22. | |
| 12804435 | Result | Moran F, Bradley J. Non-invasive ventilation for cystic fibrosis. Cochrane Database Syst Rev. 2003;(2):CD002769. doi: 10.1002/14651858.CD002769. |
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| ID | Term |
|---|---|
| D003550 | Cystic Fibrosis |
| D006935 | Hypercapnia |
| ID | Term |
|---|---|
| D010182 | Pancreatic Diseases |
| D004066 | Digestive System Diseases |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| D030342 |
| Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D007232 | Infant, Newborn, Diseases |
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |