Pleural Irrigation With a Novel Devise.

Beth Israel Lahey Health

Status: Enrolling

Conditions: Pleural Effusion Disorder

Treatments: Device: of intrapleural saline irrigation with CLR irrigator

Study type: Interventional

Funder types: Other

Identifiers

NCT06727578

2024P000822

Details and patient eligibility

About

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.

Enrollment: 10 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

Treatment

Experimental group

Treatment:

Device: of intrapleural saline irrigation with CLR irrigator