Thoracostomy Tube Irrigation: a Multi-Center Trial
United States1,000 participantsStarted 2021-12-30
Plain-language summary
All trauma patients ages 18 years or older presenting within 24 hours of blunt or penetrating injury resulting in traumatic HTx or HPTx will be eligible for enrollment. This prospective comparative study will consist of a non-irrigation control arm and a thoracic irrigation experimental arm. Thoracic irrigation is performed at the time of the initial TT placement, and is done at the discretion of the attending Trauma surgeon. All patients enrolled will be entered in a prospectively maintained thoracic trauma database. The primary outcome is need for secondary intervention, defined as additional TT placement, VATS, tissue plasminogen activator (tPA), or thoracotomy for the management of retained HTx. Secondary interventions will be screened according to indication. Only secondary interventions directed at management of retained collection will be considered in the analysis for our primary outcome. Secondary intervention aimed at persistent air leaks or post-pull PTx will be considered separately in any analysis.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* • Trauma patients admitted with initial indication for TT placement of HTx or HPTx.
* Patients must present to Methodist Dallas Medical Center within 24 hours of the traumatic event, either blunt or penetrating injury.
* Follow up data available including radiologic studies performed within 24 hours of tube placement and hospital records to determine if any additional intervention(s) was performed.
* 18 years of age or older.
Exclusion Criteria:
* Less than 18 years of age.
* Patients who had the TT removed (intentionally or unintentionally dislodged) prior to 24 hours TT duration.
* Patients requiring operative exploration of the thoracic cavity within 6 hours following TT placement.
* Patients with thoracotomy or VATS as initial treatment for HTx and/or HPTx
* Patients with TT placed for isolated PTx
* Patients who have a TT placed for HTx or HPTx more than 24 hours after presentation, or more than 24 hours after their traumatic event
* Pregnant or lactating women
* Prisoners
* Physician discretion
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.