Thopaz for PALs Evaluation

The investigators will conduct a prospective controlled clinical trial. The investigators' target demographic includes all adult patients with lung resection and/or non-lung resection-related PAL with ipsilateral chest tubes who were not candidates for surgical intervention or patients who refused the intervention. These patients would undergo a multidisciplinary review by thoracic surgery, interventional pulmonary and the primary care team to consider a bronchoscopic approach with endobronchial valves and possibly bronchial blood patch, which is currently considered standard of care at our institution. During this standard-of-care intervention, quantitative assessment of distal occluded airway pressures/flows in various airways, as well as quantitative assessment of air leak volume will be assessed.

In current medical practice, when EBVs are considered in the context of managing PALs, bronchoscopists may opt to either conduct complete lobar occlusion (sealing of all segments within the target lobe) or segmental occlusion (sealing only selected segments within the target lobe). The decision is usually guided by localizing the source of air leak which is usually done by monitoring the reduction of air leak on the pleural drainage device following serial inflation of a Fogarty Catheter at various locations within the endobronchial tree and monitoring change in air leak visually in the pleural drainage system.

In this trial, patients with PALs will have their chest tubes connected to the Thopaz+ system. The Thopaz+ will continuously quantify the volume of air leaks, providing real-time data for analysis.

Data from both the Thopaz+ and standard serial occlusion test with Fogarty balloon will be combined and integrated to provide a comprehensive assessment of the air leak source. The bronchoscopist will perform standard visual assessment of changes in air leak during serial balloon occlusion in order to identify the best region for endobronchial treatments; use of measurements from the Thopaz and serial balloon occlusion test will be allowed as part of clinical reasoning but are not required to be used by the treating clinician.

Continuous monitoring using the Thopaz+ system may continue post-procedure to track changes in air leak volumes and patient recovery, ensuring timely interventions and optimal patient outcomes. This integrated approach aims to provide a more accurate, objective, and efficient method of managing PALs compared to traditional techniques.

• Percentage of patients with identifiable lobar or segmental airways responsible for PAL [Time frame: During procedure]
• Maximum decrease in volume of air leak during serial balloon occlusion, as measured by Thopaz+ device [Time frame: During procedure]
• Treatment success: decrease of one grade in Cerfolio classification for air leaks or removal of continuous suction from chest drain. [Time frame: From enrollment until 8 weeks follow-up (as per standard of care for bronchoscopic treatment of PALs)]
• Treatment failure: no decrease in the degree of the air leak (Cerfolio classification) and the need for continuous suction for chest drain [Time frame: From enrollment until 8 weeks follow-up (as per standard of care for bronchoscopic treatment of PALs)]
• Length of stay following EBV placement [Time frame: From enrollment until 8 weeks follow-up (as per standard of care for bronchoscopic treatment of PALs)]
• Duration of chest tube following bronchoscopy [Time frame: From enrollment until 8 weeks follow-up (as per standard of care for bronchoscopic treatment of PALs)]
• Change in Air Leak Severity Graded by Cerfolio Classification [Time frame: From enrollment until 8 weeks follow-up (as per standard of care for bronchoscopic treatment of PALs)]
• Change in Quantitative Air Leak Volume Measured by Thopaz+ Digital Drainage System [Time frame: From enrollment until 8 weeks follow-up (as per standard of care for bronchoscopic treatment of PALs)]
• The need for additional non-surgical intervention [Time frame: From enrollment until 8 weeks follow-up (as per standard of care for bronchoscopic treatment of PALs)]
• The need for additional surgical intervention for PAL such as video-assisted thoracoscopic surgery with mechanical pleurodesis, blebectomy or lobectomy [Time frame: From enrollment until 8 weeks follow-up (as per standard of care for bronchoscopic treatment of PALs)]