Chest drain REgular FLushing in ComplIcated parapneumonic EFfusions and empyemas: Study protocol for the RELIEF randomized controlled trial.
Taryn K Boyle, Jennifer D Duke, Gulmira Yermakhanova...
https://pubmed.ncbi.nlm.nih.gov/41785244/Actively Recruiting
Led by Vanderbilt University Medical Center · Updated on 2026-02-20
96
Participants Needed
5
Research Sites
N/A
Total Duration
This research aims to evaluate the effect of regularly flushing chest drains in patients with complicated parapneumonic pleural effusions and empyemas, which are infections in the pleural space requiring antibiotics and chest tube drainage. The study focuses on whether flushing the chest drain with saline solution can help prevent blockages, improve drainage, and potentially reduce the length of hospital stay and need for additional interventions. This is a randomized trial addressing a practice that has not been studied in controlled trials before. Participants will be randomly assigned to one of two groups one group will receive routine flushing of their chest tube with 20 mL of sterile saline every 6 hours, administered by study team members, considering certain therapies as flushes the other group will receive saline flushes only if needed to unblock the tube, with no routine flushing. The study follows British Thoracic Society guidelines recommending flushing for small chest drains, but the overall value of this practice is being assessed. During the study, patients will be monitored for the time it takes until chest tube removal, length of hospital stay, chest x-ray improvements, the need for further surgical procedures, and any complications. These assessments will continue up to three months, with chest imaging compared at placement and removal. The study involves inpatient management and ongoing safety evaluations to understand the impact of flushing on patient outcomes.
CONDITIONS
Chest Drain Regular Flushing in Complicated Parapneumonic Effusions and Empyemas
S
Samira Shojaee, MD, MPH
J
Jennifer Duke, MD
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Vanderbilt University Medical Center
Lead Sponsor
This table compares participation in this trial with other options available for this condition. The information is drawn from published research and the trial’s study details and is provided for educational purposes only.
| Factors | Regular flushing with saline every ~6 hours | Flushing only if blockage occurs |
|---|---|---|
| What it is | A strategy of flushing chest drains with sterile saline (around 20 mL) every six hours regardless of blockage. | A strategy of flushing chest drains only when blockage is clinically suspected or occurs. |
| Role in the trial | Investigational flushing regimen tested by study investigators. | Comparator reflecting usual practice or minimal intervention control. |
| Primary use in trial | To assess whether routine flushing shortens time to chest tube removal. | To evaluate whether withholding routine flushing affects time to chest tube removal. |
| How it is done | Study team flushes the chest tube with approximately 20 mL sterile saline every six hours. | Flushing is performed only if the chest tube seems blocked, per standard practice. |
| Evidence status | Unknown — no randomized trial data yet; this RCT is designed to clarify whether frequent flushing improves outcomes. | Standard practice but lacks high‑quality evidence on its impact; evidence practice is variable. |
| Important risks | Risks are procedural and not well‑defined in trial protocol. | Risks are procedural and not detailed for contrast with flushing strategy. |
| Important limitations | Uncertainties remain whether routine flushing reduces time to tube removal and whether it introduces undue procedural burden. | May result in tube occlusion or delayed drainage; study will assess whether this affects outcomes. |
| Patient impact | Unknown until trial data are available; may affect drainage duration and hospital stay. | Unknown; could lead to variable outcomes in drainage duration, hospitalization, additional procedures or complications. |
Disclaimer: This comparison is created with the help of artificial intelligence(AI) and may contain errors or missing information. It is not medical advice and does not mean one option is better or safer than another. Clinical trials are still being studied, and joining a trial is your choice. Please consult your healthcare professional before making any decisions.
You may qualify if you...
You will not qualify if you...
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 3 months or until chest tube removal
Participants receive either regular saline flushes into their chest tube every 6 ± 2 hours or saline flushes as needed to maintain chest tube patency while managing pleural space infection.
Daily visits during chest tube management
Duration - Up to 365 days
Participants are monitored for outcomes such as length of hospitalization, radiographic improvement, complications, and need for additional surgical procedures.
Periodic visits depending on clinical status
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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Taryn K Boyle, Jennifer D Duke, Gulmira Yermakhanova...
https://pubmed.ncbi.nlm.nih.gov/41785244/Vanderbilt University Medical Center
Lead Sponsor