Bronchioscopic Lung Volume Reduction (BLVR)

NCT02415478 | Unknown

• 1 other identifier: 14-002
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Keywords

Chronic obstructive pulmonary disease (COPD); endoscopic lung volume reduction; Endobronchial valve; physical capacity; quality of life

Outcome Measures

Primary Outcomes (4)

• 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

Interventions

endoscopic lung volume reduction by valves OTHER

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patients with severe COPD (GOLD stage III or IV)

You may qualify if:

• 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

You may not qualify if:

• 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%)

Sponsors & Collaborators

• RWTH Aachen University: lead

Study Sites (1)

RWTH Univerity Hospital, Department of Cardiology, Pneumology, Vascular Medicine and Intensive Care Medicine

Aachen, 52074, Germany

RECRUITING

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Michael Dreher, Univ.-Prof.

  RWTH University Hospital MK1

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Michael Dreher, Univ.-Prof.

CONTACT

+49241 80 88763; mdreher@ukaachen.de

Tobias Müller, PD Dr.med.

CONTACT

+49241 80 88763; tobmueller@ukaachen.de

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 20, 2015
• First Posted: April 14, 2015
• Study Start: September 1, 2015
• Primary Completion: September 1, 2016
• Study Completion: December 1, 2016
• Last Updated: November 20, 2015

Record last verified: 2015-11

Locations

DE (1)