Saline flushing of the pleural space using a new irrigation device
A Pilot Assessment of the Safety and Efficacy of Pleural Irrigation for Retained Pleural Infection Using a Novel Irrigation Device
This pilot tests whether flushing the pleural space with sterile saline using the CLR irrigator can help clear retained infected pleural fluid in patients who cannot receive standard intrapleural enzyme therapy.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 10 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Beth Israel Deaconess Medical Center Academic / other |
| Locations | 1 site (Boston, Massachusetts) |
| Trial ID | NCT06727578 on ClinicalTrials.gov |
What this trial studies
This is a single-arm pilot in which patients with retained pleural effusion identified by bedside ultrasound within 24 hours of chest tube insertion receive intrapleural saline irrigation delivered with the CLR irrigator. The trial enrolls patients who are contraindicated for intrapleural enzymatic therapy and excludes non-infectious effusions and post-procedural empyema. Key outcomes include radiographic and clinical clearance of retained fluid, need for additional invasive procedures, and safety/tolerability. The procedure is performed and monitored at Beth Israel Deaconess Medical Center.
Who should consider this trial
Good fit: Adults with retained infected pleural fluid seen on bedside ultrasound within 24 hours after chest tube placement who cannot receive intrapleural enzymatic therapy are the intended candidates.
Not a fit: Patients with pleural fluid from non-infectious causes (for example malignancy) or with post-procedural empyema or complicated parapneumonic effusion are unlikely to benefit from this intervention.
Why it matters
Potential benefit: If successful, this approach could clear infected pleural collections without enzymatic therapy and reduce the need for additional invasive procedures.
How similar studies have performed: Intrapleural enzymatic therapy (tPA/DNase) has demonstrated benefit in pleural infection, but saline irrigation with the CLR device is a novel approach with limited prior data and is being tested here as a pilot.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Boston, Massachusetts
- Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States (Recruiting)
Study contacts
- Study coordinator: Christine Conley
- Email: Cconley@bidmc.harvard.edu
- Phone: 617-632-8386
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.