Chronic Obstructive Pulmonary Disease Clinical Trial
Official title:
Long-term Effects of Non-invasive Ventilation in Hypercapnic COPD Patients.
Verified date | October 2012 |
Source | FLUIDDA nv |
Contact | n/a |
Is FDA regulated | No |
Health authority | Belgium: Ethics Committee |
Study type | Interventional |
In this multicenter study the comparison of the mass flow distribution and redistribution versus the relative blood flow per lobe (as a surrogate for Ventilation/ Perfusion (V/Q) matching) with functional respiratory imaging (FRI) and arterial blood gas (ABG) values will be evaluated in hypercapnic Chronic Obstructive Pulmonary Disease (COPD) patients. Therefore a low dose Computed Tomography (CT) scan will be taken in a population of 30 patients with non-invasive ventilation (NIV) and in a control group of 10 patients without NIV. The CT-scan will be used for FRI.
Status | Terminated |
Enrollment | 40 |
Est. completion date | October 2013 |
Est. primary completion date | October 2013 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 40 Years and older |
Eligibility |
Inclusion Criteria: - Age: = 40 years old - Men and women - Written informed consent obtained - COPD patients GOLD II, III and IV - Persisting hypercapnia (pCO2 > 45 mmHg ) notwithstanding adequate treatment modalities (including oxygen) as proposed by the GOLD guidelines - Stopped smoking - Total lung capacity (TLC) > 85% Exclusion Criteria: - Treatment with home NIV or Continuous Positive Airway Pressure (CPAP) - Asthma - Restrictive lung disease - Symptomatic or uncontrolled heart failure - Current malignancy - Suspected bad compliance for NIV treatment - Pregnant women - Not be able to speak the language of the participating center - Received an investigational product within 4 weeks prior to inclusion in the study |
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Belgium | Antwerp University Hospital | Edegem | Antwerp |
Netherlands | University Medical Center Groningen | Groningen |
Lead Sponsor | Collaborator |
---|---|
FLUIDDA nv |
Belgium, Netherlands,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Changes in the distribution of the mass flow per lobe and the relative proportion of bloodvessels, as obtained from functional respiratory imaging (FRI) and arterial blood gas (ABG). | The primary objective of this study is the comparison of the mass flow distribution and redistribution versus the relative blood flow per lobe (as a surrogate for V/Q matching) with FRI and ABG values in hypercapnic COPD patients treated with long-term NIV. | At baseline, after 1 month and after 6 months of treatment with non-invasive ventilation (NIV) | No |
Secondary | Health related quality of life | Saint George's Respiratory Questionnaire (SGRQ) and Severe Respiratory Insufficiency (SRI) Questionnaire | At baseline, after 1 month and after 6 months | No |
Secondary | Lung function tests | Spirometry, reversibility, plethysmography, diffusion, Maximal Inspiratory Pressure (MIP), Maximal Expiratory Pressure (MEP) | At baseline, after 1 month and after 6 months | No |
Secondary | Hospital admissions | Length and frequency of admission, severity of exacerbations, ICU admissions | After 1 month and after 6 months | No |
Secondary | Exercise tolerance | 6 minutes walking test and oximetry measurement | At baseline, after 1 month and after 6 months | No |
Secondary | Local airway volume and resistance | CT-scan of thorax. CT scan is performed with a low radiation protocol. These images are made to perform computational fluid dynamics on in order to obtain more information on regional lung function characteristics. | At baseline, after 1 month and after 6 months | No |
Secondary | Prediction of breathing pattern | The tertiary objective of the study is to predict the breathing pattern (including tidal volume) during NIV when using the data of patient specific lobar compliance and regional resistance at baseline. | At baseline | No |
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