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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
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.
Beth Isreal Deaconess Medical Center
Boston, Massachusetts, United States
RECRUITINGIncidence of Adverse Events Following Combined Blood Patch and Spiration Valve Application
This outcome will assess the safety of the combined blood patch and Spiration valve intervention by measuring the number of participants who experience one or more adverse events. Adverse events may include valve migration, the emergence of new air leaks in lung lobes other than the treated segment, and deterioration in pulmonary function, such as worsened gas exchange or progression to respiratory failure. Units: Binary (YES/NO)
Time frame: From enrollment to the end of the observational period at 12 months post-intervention as per standard procedure
Feasibility of Combined Endobronchial Blood Patch and Spiration Valve Procedure
Defined as the successful completion of the combined autologous endobronchial blood patch and Spiration Valve procedure. Units: Binary (Yes/No - Procedure Completed as Intended)
Time frame: From enrollment to end of procedure.
Change in Air Leak Severity Based on Cerfolio Classification
This refers to the variation or progression in postoperative pulmonary air leaks, categorized based on the Cerfolio classification system. Units: Change in Cerfolio Grade (e.g., Grade 4 to Grade 2)
Time frame: From enrollment to end of observational period at 12 months post-intervention as per standard procedure
Time to Air Leak Resolution
Duration from the onset of a postoperative air leak to its complete cessation. Units: Days
Time frame: From enrollment to end of observational period at 12 months post-intervention as per standard procedure.
Change in Chest Tube Suction Requirement
This denotes the alteration in the level or need for suction applied to a chest drainage system over time. Units: cmH₂O
Time frame: From enrollment to end of observational period at 12 months post-intervention as per standard procedure
Time to Chest Tube Removal
Duration from intervention to successful removal of the chest tube, indicating resolution of the persistent air leak and adequate lung re-expansion. Units: Days
Time frame: From enrollment to end of observational period at 12 months post-intervention as per standard procedure
Subsequent Interventions Required Following Blood Patch and Valve Treatment
Incidence and nature of additional therapeutic procedures required to manage persistent air leaks following the initial combined blood patch and valve intervention. Units: Number of participants requiring ≥1 additional intervention
Time frame: From enrollment to end of observational period at 12 months post-intervention as per standard procedure
Incidence of Respiratory Infections Following Combined Blood Patch and Spiration Valve Application
This outcome will specifically evaluate the number of participants who develop respiratory infections following the intervention. Respiratory infections of interest include post-obstructive pneumonia and other clinically documented respiratory infections potentially related to the procedure. Units: Binary (YES/NO)
Time frame: From enrollment to the end of the observational period at 12 months post-intervention.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.