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

Primary Purpose

Chronic Obstructive Pulmonary Disease, Hypercapnia

Status

Terminated

Phase

Not Applicable

Locations

Germany

Study Type

Interventional

Intervention

ventilators designed for non invasive ventilation

About this trial

This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease focused on measuring non invasive ventilation, COPD, hypercapnia, GOLD stage IV

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Medizinische Hochschule Hannover

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

NPPV group

control gorup

Arm Description

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)

Subjects in this arm receive standard COPD treatment and LTOT if indicated.

Outcomes

Primary Outcome Measures

all-cause mortality

Secondary Outcome Measures

exercise capacity

Full Information

NCT ID

NCT00710541

First Posted

January 22, 2008

Last Updated

August 12, 2013

Sponsor

Deutsche Lungenstiftung e.V.

1. Study Identification

Unique Protocol Identification Number

NCT00710541

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2013

Overall Recruitment Status

Terminated

Why Stopped

The publication of a national guideline on NPPV precluded further recruitment.

Study Start Date

October 2004 (undefined)

Primary Completion Date

July 2011 (Actual)

Study Completion Date

December 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Deutsche Lungenstiftung e.V.

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Obstructive Pulmonary Disease, Hypercapnia

Keywords

non invasive ventilation, COPD, hypercapnia, GOLD stage IV

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

195 (Actual)

8. Arms, Groups, and Interventions

Arm Title

NPPV group

Arm Type

Experimental

Arm Description

Arm Title

control gorup

Arm Type

No Intervention

Arm Description

Subjects in this arm receive standard COPD treatment and LTOT if indicated.

Intervention Type

Device

Intervention Name(s)

ventilators designed for non invasive ventilation

Other Intervention Name(s)

Resmed VPAP III ST-A, Weinmann Ventimotion, Tyco Healthcare Knight Star 330

Intervention Description

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.

Primary Outcome Measure Information:

Title

all-cause mortality

Time Frame

one year

Secondary Outcome Measure Information:

Title

exercise capacity

Time Frame

one year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Carl P Criée, Professor

Organizational Affiliation

Krankenhaus Göttingen-Weende, Klinik Lenglern

Official's Role

Study Chair

Facility Information:

Facility Name

Medizinische Hochschule Hannover

City

Hannover

ZIP/Postal Code

D-30625

Country

Germany

12. IPD Sharing Statement

Citations:

PubMed Identifier

15293170

Citation

Kohnlein T, Criee CP, Kohler D, Welte T, Laier-Groeneveld G. [Multicenter study on "non-invasive ventilation in patients with severe chronic obstructive pulmonary disease and emphysema(COPD)"]. Pneumologie. 2004 Aug;58(8):566-9. doi: 10.1055/s-2004-818542. German.

Results Reference

background

PubMed Identifier

25066329

Citation

Kohnlein T, Windisch W, Kohler D, Drabik A, Geiseler J, Hartl S, Karg O, Laier-Groeneveld G, Nava S, Schonhofer B, Schucher B, Wegscheider K, Criee CP, Welte T. Non-invasive positive pressure ventilation for the treatment of severe stable chronic obstructive pulmonary disease: a prospective, multicentre, randomised, controlled clinical trial. Lancet Respir Med. 2014 Sep;2(9):698-705. doi: 10.1016/S2213-2600(14)70153-5. Epub 2014 Jul 24.

Results Reference

derived

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

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