Chest Drain Regular Flushing in Complicated Parapneumonic Effusions and Empyemas
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorVanderbilt University Medical Center
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Sequential
Treatments tested in this trial
Saline Flush
Other interventionsterile saline 20 mL flushed into their catheter by trained nurses or study team members every 6 ± 2 hours
Treatment groups
96 Participants
are divided into 2 treatment groupsGroup A: Saline Intervention ArmExperimental treatment 1 intervention
Group B: No Intervention ArmNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
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
Time frame
up to 3 monthsSecondary outcomes
1
Length of hospitalization
Time frame
up to 365 days2
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 months3
Additional surgical procedures for the management of pleural space infection
number of additional procedures through study completion
Time frame
an average of 3 months4
Complications
Time frame
through study completion, an average of 3 monthsSponsors and contacts
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Source ClinicalTrials.gov