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
Beth Israel Deaconess Medical Center
20 participants
Jul 1, 2025
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria2
- 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 Criteria3
- 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
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Interventions
This component of the procedure involves sealing persistent air leak (PAL) defects using autologous blood delivered via a balloon catheter. After identifying the target segment, carefully noting the airway angle and distal carina, a sizing balloon is deployed and inflated to ensure a tight seal. Under anesthesia, 30 mL of fresh blood is prepared and infused into the target airway until either visible extravasation occurs or the full volume is delivered. Following this, up to 10 mL of tranexamic acid (TXA) may be administered, again until extravasation occurs or the volume is fully instilled. The balloon remains inflated for 3-5 minutes after the instillation to allow clot formation and sealing of the defect.
Once the blood patch component is complete and the balloon is deflated, a Spiration Valve System (SVS) is placed proximally in the airway. The valve acts as a one-way device that decompresses the targeted lung segment while stabilizing the clot created by the blood patch. This supports durable resolution of the air leak, particularly in cases where collateral ventilation might otherwise reduce the efficacy of valve therapy alone.
Locations(1)
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NCT07184528