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

NCT01592656 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2014-01-16

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • FLUIDDA nv

    lead INDUSTRY

Principal Investigators

  • Wilfried De Backer, MD, PhD · University Hospital, Antwerp

  • Peter Wijkstra, MD, PhD · University Medical Center Groningen

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-02-28
Primary Completion
2013-10-31
Completion
2013-10-31

Countries

  • Belgium
  • Netherlands

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01592656 on ClinicalTrials.gov