Bronchioscopic Lung Volume Reduction (BLVR) (BLVR)

The Effect of Endoscopic Lung Volume Reduction Via Endobronchial Valves on Breath Muscle Power by Patients With COPD

For patients with emphysema, lung volume reduction by insertion of endobronchial valves could be an expedient approach to improve the diaphragm function and the strength of breathing muscles. Therefore in the present study investigators intend to examine, whether the lung volume reduction by valves might improve the physical capacity and the quality of life.

Study Overview

• Status: Unknown
• Conditions: Chronic Obstructive Pulmonary Disease (COPD)
• Intervention / Treatment: Other: endoscopic lung volume reduction by valves

Detailed Description

In line with routine explorations it is necessary to clarify whether a patient is suitable for the lung volume reduction by insertion of endobronchial valves. 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.

Following examination will be performed additional due to the study: determination of the strength of breathing muscles via sniff nasal pressure (PImax, PE max, P0.1), determination of the life quality index via St.-George-questionary and determination of the depression score via the Short Form 8 (SF-8) Health Survey.

After that endobronchial valve 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. Once again the determination of the strength of breathing muscles, the life quality index via St.-George-questionary and the depression score via SF-8 will be performed to clarify an improvement of the physical capacity and the quality of life

• Study Type: Observational
• Enrollment (Anticipated): 20

Contacts and Locations

• Study Contact: Name: Michael Dreher, Univ.-Prof.; Phone Number: +49241 80 88763; Email: mdreher@ukaachen.de
• Study Contact Backup: Name: Tobias Müller, PD Dr.med.; Phone Number: +49241 80 88763; Email: tobmueller@ukaachen.de

Study Locations

• Germany
  • Aachen, Germany, 52074
    • Recruiting
    • RWTH Univerity Hospital, Department of Cardiology, Pneumology, Vascular Medicine and Intensive Care Medicine
    • Contact: Michael Dreher, Univ.-Prof.; Phone Number: +492418088763; Email: mdreher@ukaachen.de
    • Contact: Tobias Müller, PD Dr.med.; Phone Number: +492418088763; Email: tobmueller@ukaachen.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

patients with severe COPD (GOLD stage III or IV)

Description

Inclusion Criteria:

• bilateral lung emphysema after CT
• 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

Exclusion Criteria:

• echo-cardiographic right ventricular pressure (PAPsys) > 50 mmHg
• indication for a permanent anticoagulation therapy (besides ASS)
• pulmonal cachexia
• pregnancy and lactating
• permanent treatment with > 20 mg Prednison per day
• hospitalisation due to a COPD-exacerbation in the last 3 months
• > 3 steroid-treated exacerbations in the last year
• Increase of FEV1 (Forced Expiratory Volume) ≥ 20% after bronchodilatation
• severe diffusion impairment (DLCO < 20%)

Study Plan

How is the study designed?

Design Details

• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Breath Muscle Power	Maximal Inspiratory Pressure (PImax)	Change of breathing strength 3 (respectively 9) months after the bronchoscopy
Breath Muscle Power	Maximal Expiratory Pressure (PEmax)	Change of breathing strength 3 (respectively 9) months after the bronchoscopy
Breath Muscle Power	Neuromuscular drive (P0.1)	Change of breathing strength 3 (respectively 9) months after the bronchoscopy
Breath Muscle Power	Sniff nasal pressure	Change of breathing strength 3 (respectively 9) months after the bronchoscopy

Collaborators and Investigators

• Sponsor: RWTH Aachen University
• Investigators: Principal Investigator: Michael Dreher, Univ.-Prof., RWTH University Hospital MK1

Study record dates

Study Major Dates

• Study Start: September 1, 2015
• Primary Completion (Anticipated): September 1, 2016
• Study Completion (Anticipated): December 1, 2016

Study Registration Dates

• First Submitted: March 20, 2015
• First Submitted That Met QC Criteria: April 8, 2015
• First Posted (Estimate): April 14, 2015

Study Record Updates

• Last Update Posted (Estimate): November 20, 2015
• Last Update Submitted That Met QC Criteria: November 18, 2015
• Last Verified: November 1, 2015

More Information

Terms related to this study

• Keywords: quality of life; Chronic obstructive pulmonary disease (COPD); Endobronchial valve; physical capacity; endoscopic lung volume reduction
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: 14-002