Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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(Viral Activation Transfusion Study), 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.
This is a multicenter observational prospective data collection study. The study was initiated by Dr. Carver at the Medical College of Wisconsin and hosted as a Western Trauma Association Multicenter trial. We will not alter our standard of care practice at Methodist Dallas Medical Center in any way during the study duration. Data abstraction will occur from the electronic medical records program (EPIC). Each participating site will also practice according to their standard of care. If a site chooses to implement a TT irrigation protocol, approval should be obtained from their local divisional and IRB(Institutional Review Board) committees. If a participating site already performs thoracic irrigation, efforts should be made to follow the TT irrigation protocol provided with this study.
Each participating site will develop a method to screen for patients based on the resources available at their institution; this method should be included in the proposal submitted to their IRB.
The data at each participating site will be collected by a member of the study team and entered into the secure REDCap (Research Electronic Data Capture) database specifically created for this project. Data will be transferred from participating sites to Medical College of Wisconsin via REDCap. REDCap is a secure web application for building and managing online databases. All data entered into REDCap and transferred between sites will be deidentified. Only approved study staff at each site will be granted password protected access to the REDCap database. Ultimately, the Medical College of Wisconsin PI will have control over who can access the database and what type of access is granted.
The aim is to have all data collection completed by December 31, 2022 and to have data analysis completed by July 1, 2022.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| control cohort | control cohort |
| |
| irrigation cohort | irrigation cohort |
| |
| standard cohort | standard cohort |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Not provided
Not provided
Inclusion Criteria:
• Trauma patients admitted with initial indication for TT placement of HTx or HPTx.
Exclusion Criteria:
Not provided
Not provided
Not provided
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.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Michael Truitt, MD | The Methodist Hospital Research Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Research Institute Methodist Health System | Dallas | Texas | 75203 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|