Chest Drain Regular Flushing in Complicated Parapneumonic Effusions and Empyemas

Pleural Infection Clinical Trial

— RELIEF  

Official title:

Chest Drain Regular Flushing in Complicated Parapneumonic Effusions and Empyemas

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06427538
• Other study ID #: 231367
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 1, 2024
• Est. completion date: October 30, 2025

Study information

• Verified date: May 2024
• Source: Vanderbilt University Medical Center
• Contact: Samira Shojaee, MD, MPH
• Phone: 615-322-2386
• Email: samira.shojaee[@]vumc.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 96
• Est. completion date: October 30, 2025
• Est. primary completion date: June 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Empyema
• Empyema, Pleural
• Flushing
• Pleural Infection

Intervention

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

Locations

Country	Name	City	State
United States	Vanderbilt University Medical Center	Nashville	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
Vanderbilt University Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	Length of hospitalization		up to 365 days
Secondary	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
Secondary	Additional surgical procedures for the management of pleural space infection	number of additional procedures through study completion	an average of 3 months
Secondary	Complications		through study completion, an average of 3 months