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Infections of the pleural space are common, and patients require antibiotics and chest drain placement to evacuate the chest from the infected fluid. Chest drains can get blocked by the drainage fluid and material. For this reason, it is thought that flushing the chest drain with saline solution, can help maintain the patency of the tube. This proposed study will evaluate the impact of regular chest drain flushing on the length of time to chest tube removal and total hospitalization as well as improvement in chest imaging and the need for additional interventions on the infected space.
There are no randomized controlled trials (RCTs) evaluating the role of regular chest tube flushing in the setting of pleural space infection for optimal drainage and treatment outcomes. Most studies of <16 Fr catheters have used both flushing and suction to decrease the likelihood of catheter blockage and improve drainage efficiency, however, this practice has never been studied prospectively or in RCTs. Regular flushing (e.g., 20-30 ml saline every 6 h via a three-way tap) is recommended for small chest drains by the British Thoracic Society (BTS) 2010 Guidelines. This practice is followed variably by some and not used by others. Importantly, the role of this practice in successful drainage of infected fluid, and patient-centric outcomes has not been investigated. Inconsistent flushing practices confound the interpretation of therapeutic modalities (such as intrapleural tissue plasminogen activator and deoxyribonuclease therapy) success or lack thereof and limit the execution of RCTs and prospective studies of the pleural space in the setting of infection.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Saline Intervention Arm | Experimental | Patient will receive 20 mL sterile saline flushes into their catheter by study team members every 6 ± 2 hours. If patients are receiving intrapleural tissue plasminogen activator and deoxyribonuclease therapy, each treatment will be considered one flush. |
|
| No Intervention Arm | No Intervention | Patient will receive a saline flush as needed, to restore patency of a chest tube considered blocked. No routine flushes will be administered. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Saline Flush | Other | sterile saline 20 mL flushed into their catheter by trained nurses or study team members every 6 ± 2 hours |
|
| Measure | Description | Time Frame |
|---|---|---|
| Time to chest tube removal | The investigators will assess the time from randomization (within 24 hours of chest tube placement) until time to chest tube removal | up to 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Length of hospitalization | up to 365 days | |
| Radiographic improvement as evidenced by chest x-ray at the time of chest tube placement compared to the time of removal | through study completion, an average of 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Samira Shojaee, MD, MPH | Contact | 615-322-2386 | samira.shojaee@vumc.org | |
| Jennifer Duke, MD | Contact | 615-322-2386 | jennifer.duke@vumc.org |
| Name | Affiliation | Role |
|---|---|---|
| Jennifer D Duke, MD | Vanderbilt University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Henry Ford | Recruiting | Sterling Heights | Michigan | 48310 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41785244 | Derived | Boyle TK, Duke JD, Yermakhanova G, Paez R, Bridwell G, Ratwani AP, Leonard KM, Chen H, Harrell FE Jr, Lentz RJ, Maldonado F, Rahman NM, Shojaee S. Chest drain REgular FLushing in ComplIcated parapneumonic EFfusions and empyemas: Study protocol for the RELIEF randomized controlled trial. PLoS One. 2026 Mar 5;21(3):e0331725. doi: 10.1371/journal.pone.0331725. eCollection 2026. |
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Deidentified data will be shared with other researchers
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| ID | Term |
|---|---|
| D016724 | Empyema, Pleural |
| D004653 | Empyema |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D013492 | Suppuration |
| D010995 | Pleural Diseases |
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| Additional surgical procedures for the management of pleural space infection | number of additional procedures through study completion | an average of 3 months |
| Complications | through study completion, an average of 3 months |
| Creighton University | Recruiting | Omaha | Nebraska | 68124 | United States |
|
| Mount Sinai | Recruiting | New York | New York | 10029 | United States |
|
| Vanderbilt University Medical Center | Recruiting | Nashville | Tennessee | 37203 | United States |
| Virginia Commonwealth University | Recruiting | Richmond | Virginia | 23298 | United States |
|
| D012140 |
| Respiratory Tract Diseases |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |