Non-invasive Ventilation in Severe Chronic Obstructive Pulmonary Disease(COPD)

August 12, 2013 updated by: Dr. Thomas Koehnlein, Deutsche Lungenstiftung e.V.

Non-invasive Ventilation in Patients With Severe Chronic Obstructive Pulmonary Disease and Lung Emphysema (COPD)

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 hypothesis, that a daily, 6 hour application of non-invasive ventilation over one year improves survival, exercise capacity, and quality of life in patients with advanced stages of COPD.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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. The lungs develop enlarged air spaces (emphysema) with a reduction of alveoli and respiratory surface. Consequences are flattening of the diaphragm and alterations in the thoracic skeleton. COPD patients in advanced stages develop insufficiency of the muscular ventilatory pump. The ventilatory pump may decompensate, if the load of the muscles overruns their capacities. Besides that, an unphysiologically high proportion of the cardiac pump volume must be spent for the demands of the ventilatory muscles. Hypercapnia, and later hypoxaemia, are indicators of a decompensated ventilatory pump.

Theoretically, non-invasive ventilation (NIV) could be a treatment option for patients with advanced COPD and insufficiency of their ventilatory pump. Mechanical non-invasive ventilation provides support for the ventilatory muscles and might counterbalance the elevated intrinsic PEEP.

The physiologic and quality of life aspects of long term application on non-invasive ventilation (over at least one year) will be assessed in this study.

Study Type

Interventional

Enrollment (Actual)

195

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Hannover, Germany, D-30625
        • Medizinische Hochschule Hannover

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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 Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: NPPV group
Subjects in this arm receive standard COPD treatment, LTOT if indicated, and NPPV with ventilators designed for 'non invasive ventilation'(Resmed VPAP III ST-A, Weinmann Ventimotion, Tyco Healthcare Knight Star 330)
Device: ventilators designed for non invasive ventilation
Patients are advised to use the ventilator for non invasive ventilation as long term treatment for at least 6 hours per day over one year.
Other Names:
  • Resmed VPAP III ST-A
  • Weinmann Ventimotion
  • Tyco Healthcare Knight Star 330
No Intervention: control gorup
Subjects in this arm receive standard COPD treatment and LTOT if indicated.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
all-cause mortality
Time Frame: one year
one year

Secondary Outcome Measures

Outcome Measure
Time Frame
exercise capacity
Time Frame: one year
one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Deutsche Lungenstiftung e.V.

Investigators

  • Study Chair: Carl P Criée, Professor, Krankenhaus Göttingen-Weende, Klinik Lenglern

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2004

Primary Completion (Actual)

July 1, 2011

Study Completion (Actual)

December 1, 2012

Study Registration Dates

First Submitted

January 22, 2008

First Submitted That Met QC Criteria

July 3, 2008

First Posted (Estimate)

July 4, 2008

Study Record Updates

Last Update Posted (Estimate)

August 14, 2013

Last Update Submitted That Met QC Criteria

August 12, 2013

Last Verified

August 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • COPD-Study
  • COPD1 (Deutsche Lungenstiftung)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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