NCT01592656

Long-term Effects of Non-invasive Ventilation in Hypercapnic Chronic Obstructive Pulmonary Disease (COPD) Patients

Long-term Effects of Non-invasive Ventilation in Hypercapnic COPD Patients.

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: FLUIDDA nv · Industry
• Sex: All
• Age: 40 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Chronic Obstructive Pulmonary Disease

Interventions

Type	Name	Description
RADIATION	Functional Respiratory Imaging	CT-scan of thorax. At baseline, after 1 month and after 6 months.
OTHER	Lung compliance measurement	At baseline
DEVICE	Non-invasive ventilation (Respironics)	Long-term non-invasive ventilation, starting at baseline until 6 months. At baseline the patients should have persisting hypercapnia (pCO2 \> 45 mmHg) under optimal conservative treatment other than NIV. The patients can be hospitalised or being treated at home at inclusion.

Timeline

• Start date: 2011-02-01
• Primary completion: 2013-10-01
• Completion: 2013-10-01
• First posted: 2012-05-07
• Last updated: 2014-01-16

Locations

2 sites across 2 countries: Belgium, Netherlands