Pleural Irrigation With a Novel Devise.

Not Applicable

Not yet recruiting

• Conditions: Pleural Effusion Disorder

• Registration Number: NCT06727578
• Lead Sponsor: Beth Israel Deaconess Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-11-01
• Study First Submitted QC: 2024-12-09
• Study First Posted: 2024-12-11
• Status Verified: 2025-03
• Last Update Submitted: 2025-05-21
• Study Start: 2025-05-25
• Last Update Posted: 2025-05-25
• Primary Completion: 2026-05-25
• Study Completion: 2026-07-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 10

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Radiographic improvement (reduction in the ammount of pleural effusion messured in centimeters) by bed side ultrasound day 1,2,3,4,5.	Daily for 8 days