NCT02415478

Bronchioscopic Lung Volume Reduction (BLVR)

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 20 (estimated)
• Sponsor: RWTH Aachen University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

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

Conditions

• Chronic Obstructive Pulmonary Disease (COPD)

Interventions

Type	Name	Description
OTHER	endoscopic lung volume reduction by valves	Independent of the study, subject will get a bronchoscopy with chartis measurement in general anaesthesia. chartis measurement is a Balloon angioplasty. Balloon will be well-positioned in lung and filled by air for occlusion of lobe of the lung. System recognizes collateral ventilation of lobe of the lung via calculation of airflow resistance. Negative result allows the endoscopic placement of selfexpandig endobronchial valves in the subject lung. Inhale airflow will be inhibit an enclosed air and liquids can exhaust.

Timeline

• Start date: 2015-09-01
• Primary completion: 2016-09-01
• Completion: 2016-12-01
• First posted: 2015-04-14
• Last updated: 2015-11-20

Locations

1 site across 1 country: Germany