Thopaz for PALs Evaluation
Utility of the Thopaz+ System in Evaluating Persistent Air Leaks
Kai Swenson
20 participants
Jan 1, 2026
OBSERVATIONAL
Conditions
Summary
Persistent air leaks (PALs) are a common postoperative complication resulting from tears in the visceral pleura or peripheral lung resections. Although highly prevalent with significant consequences, traditional assessment methods lack the capability to objectively quantify air leaks, which further complicates management, results in inconsistent decision making, and prolongs hospital stays. By incorporating the Thopaz+ system, the investigators can introduce a reliable approach to objectively quantify air leaks, potentially improving clinical outcomes. The purpose of this protocol is to perform a pilot prospective controlled clinical trial to evaluate the utility of incorporating the Thopaz+ system and its volume quantification ability in evaluating patients with persistent air leaks (PALs) to guide treatment decisions, specifically endobronchial valves (EBVs). In the targeted cohort, the Thopaz+ will be connected to the chest tube and the data collected will be combined with that of serial balloon occlusion testing with a Fogarty balloon to accurately localize the air leak source, and subsequently consider the correct placement of EBVs. The investigators will thereby determine whether this experimental strategy will yield a more accurate and objective assessment of air leaks, facilitating timely interventions and improved patient outcomes.
Eligibility
Inclusion Criteria4
- Age ≥ 18 years
- Hospitalized with a persistent air leak (PAL) lasting ≥5 days despite continuous chest tube drainage.
- Undergoing bronchoscopy as part of clinical care for PAL management.
- Able and willing to provide written informed consent
Exclusion Criteria3
- Contraindications to bronchoscopy or EBV placement.
- Pregnancy.
- Inability to tolerate general anesthesia.
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Interventions
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 bronchoscopic 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.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT07105436