Lung Volume Reduction Via Coils in Patients With COPD

Sponsor

RWTH Aachen University (Other)

Overall Status

Unknown status

CT.gov ID

NCT02246569

Collaborator

(none)

Enrollment

Location

Duration (Months)

1.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

For patients with emphysema lung volume reduction (ELVR) could be an expedient approach for the reduction of distension of the lung. ELVR may be performed using RePneu® Coils. After the insertion of the coils distended lung sections shrink so that healthy parts can expand.

In the present study investigators intend to examine, whether the insertion of the coils improves diaphragm function and force of the breathing muscles. Investigators hypothesize that reduction of lung volume eliminates or reduces flattening of the diaphragm and relieves breathing muscles, respectively respiratory pump, which aims to reduce dyspnea.

Condition or Disease	Intervention/Treatment	Phase
Chronic Obstructive Pulmonary Disease (COPD)

Detailed Description

In line with routine explorations it is necessary to clarify whether a patient is suitable for the endoscopic lung volume reduction. To address this question lung function diagnostics, 6-minutes-walk-test, blood withdrawal, CT of the thorax, lung perfusion scintigraphy and transthoracic echocardiography have to be performed.

After confirmation of the suitability for the endoscopic lung volume reduction patients who fulfill all other eligibility criteria will be educated about the aim and performance of the study by an investigator. After reading the patient information patient may submit his informed written consent. After that information on the risks will be given by a treating physician.

Following examination will be performed additional due to the study: determination of the strength of breathing muscles, determination of the life quality index via St.-George-questionary and determination of the depression score via SF-8-questionary (short form-8).

After that coils will be implanted and a permanent post-operative examination will be performed for 24 hours.

Three, respectively nine month after the implanting follow up exploration will be performed on the study patients.

Study Design

Study Type:

Observational

Anticipated Enrollment :

20 participants

Time Perspective:

Prospective

Official Title:

Impact of Endoscopic Lung Volume Reduction Via Coils on Inspiratory Muscle Strength in Patients With COPD

Study Start Date :

Oct 1, 2015

Anticipated Primary Completion Date :

Sep 1, 2016

Anticipated Study Completion Date :

Sep 1, 2016

Outcome Measures

Primary Outcome Measures

breathing strength [Change of breathing strength 3 (respectively 9) months after the bronchoscopy]
Maximal Inspiratory Pressure (PImax) Maximal Expiratory Pressure (PEmax) Neuromuscular drive (P0.1) Sniff nasal pressure

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

bilateral lung emphysema after CT with sufficient amount of tissue to perform RePneu Coil implantation at the discretion of the treating physicians
homogeneous or heterogeneous emphysema
previous guidelines-based therapy of COPD (including vaccinations against Pneumococcal infections and seasonal influenza)
nicotine abstention for not less than three months, documented by CO-HB (haemoglobin) < 2%
FEV 1 (Forced Expiratory Volume 1 / one second capacity) ≤ 45% of reference value, after bronchodilatation
total lung capacity (TLC) ≥ 100% of reference value
residual volume (RV) ≥ 175% of reference value
patient's suitability for endoscopic lung volume reduction according to multidisciplinary decision of pneumology and thorax surgery division.
signed Informed Consent
understanding of the nature, significance and implications of the study
ability to understand and follow instructions of the study stuff