PATCHVALVE Trial: A Prospective Evaluation of Blood Patch and Endobronchial Valves for Persistent Air Leaks - Pilot Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Incidence of Adverse Events Following Combined Blood Patch and Spiration Valve Application
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
Bronchoscopic Endobronchial Valve and Blood Patch Treatment Group for Persistent Air Leak Management
This study will enroll patients with persistent air leaks (PAL) following lung resection or unrelated to lung resection, who have ipsilateral chest tubes in place and are either not suitable candidates for surgical intervention or have declined surgery. Participants will undergo a combined bronchoscopic approach involving endobronchial valve (EBV) placement and endobronchial blood-patch application, aiming to effectively manage air leaks through a minimally invasive, nonsurgical technique.
Intervention: Endobronchial Blood Patch (Device)
Bronchoscopic Endobronchial Valve and Blood Patch Treatment Group for Persistent Air Leak Management
This study will enroll patients with persistent air leaks (PAL) following lung resection or unrelated to lung resection, who have ipsilateral chest tubes in place and are either not suitable candidates for surgical intervention or have declined surgery. Participants will undergo a combined bronchoscopic approach involving endobronchial valve (EBV) placement and endobronchial blood-patch application, aiming to effectively manage air leaks through a minimally invasive, nonsurgical technique.
Intervention: Spiration Valve System (SVS) Placement (Device)
Outcomes
Primary Outcomes
Incidence of Adverse Events Following Combined Blood Patch and Spiration Valve Application
Time Frame: 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
Time Frame: 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 Outcomes
- 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 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.)
- 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)
- Time to Air Leak Resolution(From enrollment to end of observational period at 12 months post-intervention as per standard procedure.)
- Change in Chest Tube Suction Requirement(From enrollment to end of observational period at 12 months post-intervention as per standard procedure)
- Time to Chest Tube Removal(From enrollment to end of observational period at 12 months post-intervention as per standard procedure)
Investigators
Jason A Beattie
Principal Investigator
Beth Israel Deaconess Medical Center