NCT06727578RecruitingNot Applicable
A Pilot Assessment of the Safety and Efficacy of Pleural Irrigation for Retained Pleural Infection Using a Novel Irrigation Device
Beth Israel Deaconess Medical Center2 sites in 1 country10 target enrollmentStarted: May 25, 2025Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 10
- Locations
- 2
- Primary Endpoint
- Radiographic improvement (reduction in the ammount of pleural effusion messured in centimeters) by bed side ultrasound day 1,2,3,4,5.
Study Overview
Brief Summary
Single-arm pilot trial of the use of intrapleural saline irrigation to treat retained pleural infections for patients with contraindications to standard of care intrapleural enzymatic therapy.
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
- •Retained pleural effusion identified via bedside ultrasound within the first 24 hours after chest tube insertion
- •Patient is contraindicated from receiving intrapleural enzymatic therapy within the first 24 hours after chest tube insertion
Exclusion Criteria
- •Non-infectious cause of pleural fluid analysis findings listed above identified (e.g. malignancy)
- •Post-procedural empyema or complicated parapneumonic effusion
Outcomes
Primary Outcomes
Radiographic improvement (reduction in the ammount of pleural effusion messured in centimeters) by bed side ultrasound day 1,2,3,4,5.
Time Frame: Daily for 8 days
Secondary Outcomes
No secondary outcomes reported
Investigators
Adnan Majid, MD
Chief, Section of Interventional Pulmonology, Division of Thoracic Surgery and Interventional Pulmonology, Beth Israel Deaconess Medical Center, Professor of Medicine, Harvard Medical School,
Beth Israel Deaconess Medical Center
Study Sites (2)
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