Chest Drain Regular Flushing in Complicated Parapneumonic Effusions and Empyemas

Обзор

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.

Подробное описание

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.

Вмешательства

• Другое Saline Flush
  sterile saline 20 mL flushed into their catheter by trained nurses or study team members every 6 ± 2 hours

Первичные конечные точки

• Time to chest tube removal [Срок оценки: up to 3 months]

Вторичные конечные точки (4)

• Length of hospitalization [Срок оценки: 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 [Срок оценки: through study completion, an average of 3 months]
• Additional surgical procedures for the management of pleural space infection [Срок оценки: an average of 3 months]
• Complications [Срок оценки: through study completion, an average of 3 months]

Критерии участия

Критерии включения

• Patients with complicated parapneumonic pleural effusion and empyema requiring chest tube placement as standard of care for inpatient management of their pleural space infection with or without intrapleural tissue plasminogen activator and deoxyribonuclease therapy
• Age > 18 years old.

Критерии исключения

• Patients who have surgical tubes that can't accommodate a three-way stopcock.
• Study subject has any disease or condition that interferes with the safe completion of the study.
• Inability to provide informed consent.
• Inability to undergo a chest X-ray.
• If the managing clinician believes the chest tube will be placed for less than 24 hours.
• Patients with an indwelling pleural catheter (IPC)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Последовательный дизайн

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 5 центров

• Henry Ford — Sterling Heights
• Creighton University — Omaha
• Mount Sinai — New York
• Vanderbilt University Medical Center — Nashville
• Virginia Commonwealth University — Richmond

Публикации

• 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. PMID 41785244

Идентификаторы

NCT: NCT06427538 · 231367

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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