Effect of Non-Invasive Ventilation in Cystic Fibrosis Patient With Chronic Respiratory Failure.

Sponsor

Cochin Hospital (Other)

Overall Status

Terminated

CT.gov ID

NCT00208078

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

0.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

There is no randomised controlled trials to determine the clinical effects of long term Non-Invasive Ventilation in Cystic Fibrosis patients.

Condition or Disease	Intervention/Treatment	Phase
Cystic Fibrosis Chronic Respiratory Failure	Device: pressure support ventilator	Phase 4

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 (4H/day). The follow up time will be one year for each patient.

Study Design

Study Type:

Interventional

Actual Enrollment :

36 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (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.

Study Start Date :

May 1, 2005

Actual Primary Completion Date :

May 1, 2010

Actual Study Completion Date :

May 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
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

Arm

Intervention/Treatment

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

Outcome Measures

Primary Outcome Measures

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]

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Confirmed diagnosis of Cystic fibrosis
Chronic hypercapnia on room air in stable condition (PaCO2 between 45 and 55mmHg in two occasions separated by more than 4 weeks)
Informed consent