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Thoracostomy Tube Irrigation: a Multi-Center Trial
Sponsor: Methodist Health System
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.
Official title: Thoracostomy Tube Irrigation: a Multi-Center Trial Investigating Its Efficacy in the Reduction of Secondary Intervention for the Management of Retained Hemothorax
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
1000
Start Date
2021-12-30
Completion Date
2024-12-31
Last Updated
2024-11-20
Healthy Volunteers
No
Conditions
Interventions
thoracic irrigation
We will start this study using 20% as the approximate national intervention rate, based on current literature, with the goal of detecting a 50% reduction in the experimental arm (i.e. 10% secondary intervention rate after thoracic irrigation). Therefore, we will plan to enroll 108 patients in the irrigation cohort and 324 patients in the control cohort. An interim analysis will be conducted once 54 patients have been enrolled in the irrigation cohort. The secondary intervention rate in the irrigation cohort and the standard cohort will be determined, and any adjustments to sample size will be made at that time.
Locations (1)
Clinical Research Institute Methodist Health System
Dallas, Texas, United States