Clinical trial NCT06427538: Chest Drain Regular Flushing in Complicated Parapneumonic Effusions and Empyemas
Official title: Chest Drain Regular Flushing in Complicated Parapneumonic Effusions and Empyemas
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Empyema, Pleural
Pleural Infection
Keywords: empyema
pleural infection
chest tube
saline flush
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
First posted: 2024-05-24
Enrollment: 96
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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)

Primary outcomes:
measure: Time to chest tube removal
timeFrame: up to 3 months
Secondary outcomes:
measure: Length of hospitalization
timeFrame: up to 365 days
measure: Radiographic improvement as evidenced by chest x-ray at the time of chest tube placement compared to the time of removal
timeFrame: through study completion, an average of 3 months
measure: Additional surgical procedures for the management of pleural space infection
timeFrame: an average of 3 months
measure: Complications
timeFrame: through study completion, an average of 3 months
Other outcomes:
Locations:
city: New York City
country: United States
facility: Mount Sinai
state: New York
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: Richmond
country: United States
facility: Virginia Commonwealth University
state: Virginia
Study officials:
affiliation: Vanderbilt University
name: Jennifer D Duke, MD
role: STUDY_DIRECTOR
References: