Status:
TERMINATED
Non-invasive Ventilation in Severe Chronic Obstructive Pulmonary Disease(COPD)
Lead Sponsor:
Deutsche Lungenstiftung e.V.
Conditions:
Chronic Obstructive Pulmonary Disease
Hypercapnia
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Non-invasive ventilation is frequently applied in patients with acute exacerbation of COPD, but no evidence exists about the effect of long term application/home application. This study tests the hyp...
Detailed Description
The key problem of COPD (Chronic Obstructive Pulmonary Disease) is chronic inflammation and obstruction of the small airways. This results in a largely elevated flow resistance and work of breathing. ...
Eligibility Criteria
Inclusion
- Moderate or severe COPD with insufficiency of the ventilatory pump (according to GOLD stage IV). Stable disease since four weeks or more prior to randomisation. The COPD might be caused by whatever reason (smoking, Alpha-1 antitrypsin deficiency, ....). Smokers can be included.
- Capillary PCO2 of 7 kPa (51,8 mmHg) or maximally 10 kPa (74 mmHg), combined with a pH of 7.35 or above. These gases must be measured after 30 minutes breathing room air in sitting position. Patients on long term oxygen treatment must inhale oxygen in their prescribed dose.
- Only patients in the age of 18 years or above can be included.
- Written information about all aspects of the study (available in German language) must be provided for each patient. Written informed consent prior to any measure of this protocol is necessary for inclusion.
Exclusion
- Patients with a PCO2 of 10 kPa (74 mmHg) or above. These patients can be re-evaluated for inclusion after 4 weeks.
- Diseases of the lung or thorax besides COPD: Advanced pulmonary fibrosis, advanced bronchiectases, active tuberculosis, post tuberculosis syndrome, pneumonia, severe kyphoscoliosis, tracheostoma, neuromuscular diseases, or any other disorder, which might result in elevated PCO2.
- Patients on NIV.
- Body mass index of 35 kg/m² or above.
- Severe cardiac disease, NYHA IV, instable angina, severe cardiac arrhythmia, especially of ventricular origin (atrial fibrillation is not an exclusion criterion).
- Malignoma
- Disorders of the basal brain nerves with derangement of swallowing, or reflexes of swallowing and choking.
- Local derangement of the face, skin, tongue, upper airways, larynx and upper oesophagus.
- Severe chronic diseases except COPD, hindering the patient to follow the schedule of this study.
Key Trial Info
Start Date :
October 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2012
Estimated Enrollment :
195 Patients enrolled
Trial Details
Trial ID
NCT00710541
Start Date
October 1 2004
End Date
December 1 2012
Last Update
August 14 2013
Active Locations (1)
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1
Medizinische Hochschule Hannover
Hanover, Germany, D-30625