Investigating the changes in physiological function following bronchoscopic lung volume reduction treatment of chronic obstructive pulmonary disease (COPD)

Not Applicable

Recruiting

• Conditions: Chronic Obstructive Pulmonary Disease; Emphysema; Respiratory physiology; Cardiac Physiology; Cor Pulmonale; Pulmonary Vascular Resistance; Exercise Physiology; Respiratory - Chronic obstructive pulmonary disease; Cardiovascular - Diseases of the vasculature and circulation including the lymphatic system; Physical Medicine / Rehabilitation - Other physical medicine / rehabilitation

• Registration Number: ACTRN12618001805268
• Lead Sponsor: niversity of Adelaide

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-11-06
• Last Update Posted: 15 July 2019

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

Established diagnosis of COPD with hyperinflation: post-bronchodilator FEV1 <50% of predicted AND TLC > 100% AND RV>175%
- The absence of any collateral ventilation between target lobe and ipsilateral lobe, diagnosed with quantitative CT fissure integrity of >90% and confirmation of integrity with Chartis measurement.
- Age >18 and <75 at the time of enrolment.
- 6-min walk test distance >150m following successful completion of a pulmonary rehabilitation program (or equivalent program).
- No evidence of significant coexistent pulmonary pathology on HRCT
- Able to safely undergo sedation or general anesthesia and bronchoscopy
- Cessation of smoking for 3 months prior

Exclusion Criteria

Any patient deemed not suitable for EBV insertion based on internationally accepted best-practice guidelines. Considerations include:
- Significant co-existent pulmonary pathology
- Severe Hypercapnia (pCO2 > 60mmHg on room air)
- Unstable cardiovascular disease
- Severe heart failure: EF <35%
- Unstable cardiac arrhythmia, myocardial infarction or stroke within 6 months
- Severe PAH: RVSP >45mmHg
- Current Smoker
- 6MWT distance less than 150m post pulmonary rehabilitation or equivalent program
- FEV1 <15% predicted
- Any device or foreign object deemed unsafe for MRI (e.g. Pacemaker, shrapnel etc.)
- Pregnancy or potentially pregnant
- Egg or protein allergies

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
A change in VO2 max based on a Cardiopulmonary Maximum Workrate Test[3 months following bronchoscopic lung volume reduction (BLVR) therapy];A change in exercise endurance time based on a CPET Constant work rate test set at 75% of the maximum workload of the maximum effort CPET[3 months post-BLVR]