Chest drain REgular FLushing in ComplIcated parapneumonic EFfusions and empyemas: Study protocol for the RELIEF randomized controlled trial

TL;DR

This study will test if regularly flushing chest drains improves recovery for patients with pleural infections compared to flushing only when needed.

Contribution

RELIEF is the first randomized controlled trial to evaluate chest drain flushing protocols in pleural infections with patient-centered outcomes.

Findings

The trial will assess if regular flushing reduces time to chest drain removal.

Secondary outcomes include hospitalization length and radiographic improvement.

A multi-state transition model will analyze longitudinal clinical outcomes.

Abstract

Pleural infections are common and drainage of the pleural space, in addition to antimicrobial therapy, is often required for adequate treatment. Guidelines suggest flushing small bore chest drains with 20–30 mL of saline every six hours, however, no randomized controlled trials (RCTs) have assessed if this practice improves outcomes for pleural space infections. As a result, flushing practice is varied, inconsistent, and confounds the interpretation of studied therapeutic modalities in pleural space infection trials. The impact of regular chest drain flushing compared to as-needed flushing on length of time to chest tube removal is unclear.

Chest Drain REgular FLushing in ComplIcated Parapneumonic EFfusions and Empyemas (RELIEF) is a multi-center, open label randomized controlled trial conducted in the United States. Patients with a pleural space infection requiring chest drain placement for inpatient management will be screened for eligibility. Patients will be randomized within 24 hours of chest drain placement to a regular flushing protocol versus as-needed flushing for drain blockage. The primary outcome is time from randomization until time to chest drain removal (hours). Secondary outcomes are length of hospitalization, degree of radiographic improvement by chest X-ray, ultrasound or CT scan from time of drain placement to time of removal, need for additional procedures for the management of pleural space infection, and complications. An ordinal, multi-state transition model will be used to precisely characterize the role of flushing in longitudinal clinical outcomes in the two arms.

RELIEF is a multi-center, open label randomized controlled trial that compares a regular saline flushing protocol with as-needed saline flushing of small-bore chest drains (8–20Fr) for the management of pleural space infection. This will be the first randomized controlled trial evaluating flushing protocol with patient-centered outcomes in pleural space infections.

The trial was registered in ClinicalTrials.gov (NCT06427538) on 05-10-2024.

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