Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06427538

Chest Drain Regular Flushing in Complicated Parapneumonic Effusions and Empyemas

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.

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Henry Ford, Sterling Heights, Michigan, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Saline Flush

Other

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

Primary outcomes

  1. Time to chest tube removal

    Time frame: up to 3 months

    The investigators will assess the time from randomization (within 24 hours of chest tube placement) until time to chest tube removal

Secondary outcomes

  1. Length of hospitalization

    Time frame: up to 365 days

  2. Radiographic improvement as evidenced by chest x-ray at the time of chest tube placement compared to the time of removal

    Time frame: through study completion, an average of 3 months

  3. Additional surgical procedures for the management of pleural space infection

    Time frame: an average of 3 months

    number of additional procedures through study completion

  4. Complications

    Time frame: through study completion, an average of 3 months

Study contacts

Contact information is provided by the study sponsor or research team.

Jennifer Duke, MD

CONTACT

[email protected]

615-322-2386

Samira Shojaee, MD, MPH

CONTACT

[email protected]

615-322-2386

Sponsors and collaborators

Lead sponsor

Vanderbilt University Medical Center

Other

Registry information

Acronym: RELIEF

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
May 24, 2024
Registry last updated
Feb 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.