PATCHVALVE: Endobronchial Valves Plus Blood Patch for Persistent Air Leaks

Not Applicable

Recruiting

• Conditions: Persistent Air Leaks

• Registration Number: NCT07184528
• Lead Sponsor: Beth Israel Deaconess Medical Center

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 Timeline

• Study Start: 2025-07-01
• Study First Submitted: 2025-08-25
• Status Verified: 2025-09
• Study First Submitted QC: 2025-09-17
• Last Update Submitted: 2025-09-17
• Study First Posted: 2025-09-22
• Last Update Posted: 2025-09-22
• Primary Completion: 2026-07-01
• Study Completion: 2027-07-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
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)
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)
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
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

Trial Locations

Locations (1)

Beth Isreal Deaconess Medical Center; 🇺🇸 Boston, Massachusetts, United States