Chest Drain Regular Flushing in Complicated Parapneumonic Effusions and Empyemas

NCT ID: NCT06427538

Last Updated: 2025-08-08

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 96 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-06-21
• Study Completion Date: 2026-03-30

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.

Conditions

Empyema, Pleural; Pleural Infection

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Saline Intervention Arm

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.

Group Type: EXPERIMENTAL

Saline Flush

Intervention Type: OTHER

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

No Intervention Arm

Patient will receive a saline flush as needed, to restore patency of a chest tube considered blocked. No routine flushes will be administered.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Saline Flush

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

Intervention Type: OTHER

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Vanderbilt University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Samira Shojaee

Associate Professor of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jennifer D Duke, MD

Role: STUDY_DIRECTOR

Vanderbilt University

Locations

Henry Ford

Sterling Heights, Michigan, United States

Site Status: RECRUITING

Creighton University

Omaha, Nebraska, United States

Site Status: RECRUITING

Mount Sinai

New York, New York, United States

Site Status: RECRUITING

Vanderbilt University Medical Center

Nashville, Tennessee, United States

Site Status: RECRUITING

Virginia Commonwealth University

Richmond, Virginia, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Samira Shojaee, MD, MPH

Role: CONTACT

samira.shojaee@vumc.org

615-322-2386

Jennifer Duke, MD

Role: CONTACT

jennifer.duke@vumc.org

615-322-2386

Facility Contacts

Labib Debiane, MD

Role: primary

ldebian1@hfhs.org

800-436-7936

Zachary S DePew, MD

Role: primary

zachary.depew@commonspirit.org

402-717-9600

Udit S Chaddha

Role: primary

udit.chaddha@mssm.edu

212-241-5656

Danai Khemasuwan

Role: primary

Danai.Khemasuwan@vcuhealth.org

804-828-6396

Other Identifiers

231367

Identifier Type: -

Identifier Source: org_study_id