Persistent Air Leaks
Conditions
Keywords
persistent air leaks, Endobronchial Valves, Spiration Valve System, Endobronchial Blood Patch, Intrabronchial Valves
Brief 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.
Detailed description
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.
Interventions
DEVICEEndobronchial Blood Patch
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.
DEVICESpiration Valve System (SVS) Placement
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.
Sponsors
Beth Israel Deaconess Medical Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
{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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Adverse Events Following Combined Blood Patch and Spiration Valve Application | From enrollment to the end of the observational period at 12 months post-intervention as per standard procedure | 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) |
| Feasibility of Combined Endobronchial Blood Patch and Spiration Valve Procedure | From enrollment to end of 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Chest Tube Suction Requirement | From enrollment to end of observational period at 12 months post-intervention as per standard procedure | This denotes the alteration in the level or need for suction applied to a chest drainage system over time. Units: cmH₂O |
| Time to Chest Tube Removal | From enrollment to end of observational period at 12 months post-intervention as per standard procedure | Duration from intervention to successful removal of the chest tube, indicating resolution of the persistent air leak and adequate lung re-expansion. Units: Days |
| Change in Air Leak Severity Based on Cerfolio Classification | From enrollment to end of observational period at 12 months post-intervention as per standard procedure | 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) |
| Incidence of Respiratory Infections Following Combined Blood Patch and Spiration Valve Application | From enrollment to the end of the observational period at 12 months post-intervention. | 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) |
| Subsequent Interventions Required Following Blood Patch and Valve Treatment | From enrollment to end of observational period at 12 months post-intervention as per standard procedure | 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 to Air Leak Resolution | From enrollment to end of observational period at 12 months post-intervention as per standard procedure. | Duration from the onset of a postoperative air leak to its complete cessation. Units: Days |
Countries
United States
Contacts
Primary ContactJason Beattie, MD
Backup ContactChristine Conley, MD
Outcome results
None listed