Thoracostomy Tube Irrigation: a Multi-Center Trial

NCT05935267 | Active Not Recruiting

• 1 other identifier: 039.GME.2021.D
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Thoracic Trauma

Outcome Measures

Primary Outcomes (1)

• Number of participants with thoracic trauma

  thoracic trauma resulting in the formation of pneumothorax (PTx), hemothorax (HTx), or hemopneumothorax (HPTx) is successfully managed with thoracostomy tube (TT) placement to evacuate blood and / or air from the pleural space.

  Dec 2022 - Dec 2023

Study Arms (3)

control cohort

control cohort

Procedure: thoracic irrigation

irrigation cohort

irrigation cohort

Procedure: thoracic irrigation

standard cohort

standard cohort

Procedure: thoracic irrigation

Interventions

thoracic irrigation PROCEDURE

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.

control cohort; irrigation cohort; standard cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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.
• years of age or older.

You may not qualify if:

• 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

Sponsors & Collaborators

• Methodist Health System: lead

Study Sites (1)

Clinical Research Institute Methodist Health System

Dallas, Texas, 75203, United States

Location

Study Officials

• Michael Truitt, MD

  The Methodist Hospital Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 21, 2022
• First Posted: July 7, 2023
• Study Start: December 30, 2021
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: November 20, 2024

Record last verified: 2024-11

Locations

US (1)