PATCHVALVE: Endobronchial Valves Plus Blood Patch for Persistent Air Leaks

PATCHVALVE Trial: A Prospective Evaluation of Blood Patch and Endobronchial Valves for Persistent Air Leaks - Pilot Study

The goal of this study is to evaluate the real-world safety and effectiveness of combining endobronchial valve (IBV) placement with endobronchial blood patching (EBP) for the treatment of persistent air leaks (PALs) in adult patients undergoing bronchoscopy. PALs are a challenging condition often associated with prolonged hospital stays, increased morbidity, and delayed recovery.

The main questions this study aims to answer are:

• Does the combination of endobronchial valve placement and endobronchial blood patching accelerate resolution of persistent air leaks?
• What are the procedural outcomes, complications, and hospital-related metrics (e.g., chest tube duration, length of stay, and readmission rates) associated with this technique?

Participants will:

• Undergo standard-of-care bronchoscopy with identification of air leak source.
• Receive intrabronchial instillation of autologous blood and tranexamic acid (TXA) followed by balloon occlusion and endobronchial valve placement.
• Be followed for resolution of air leak and post-procedure outcomes through standard inpatient monitoring and data collection.

This study will include a prospective cohort of adult patients with persistent air leaks (PALs) undergoing bronchoscopy. The intervention evaluated is a combination approach that includes endobronchial valve placement and instillation of autologous blood with tranexamic acid (TXA), followed by balloon occlusion (referred to as "PATCHVALVE" technique).

Patients will be enrolled and undergo standard imaging and procedural evaluations. For prospective participants, informed consent will be obtained prior to the procedure.

Procedural steps include:

• Identification of the leaking segment using imaging and air leak assessment.
• Instillation of fresh autologous blood (up to 30 mL) followed by TXA (up to 10 mL) via a balloon catheter into the leaking airway segment.
• Balloon occlusion for 3-5 minutes to promote clotting and adherence.
• Deployment of endobronchial valves based on standard criteria.
• Leak reassessment and iterative treatment if necessary.

This study will provide early evidence on the efficacy of this combined approach and help standardize care protocols for managing PALs non-surgically.

{Inclusion Criteria}

• Adult (≥18 years) patients who have been diagnosed with persistent air leaks (PALs) due to conditions such as alveolar-pleural fistulas following pulmonary resections, traumatic injury, or underlying lung disease or other cause.
• PAL patients who are deemed non-candidates for surgical intervention or have declined surgery.

{Exclusion Criteria}

• Patients who have received other experimental or investigational treatments for PALs that could confound the results.
• Patients with contraindications to undergoing bronchoscopy, such as severe cardiovascular instability, or those who cannot tolerate the procedure due to other medical reasons.
• Bronchopleural fistula