Traumatic Hemothorax Drainage and Daily Lavage: Pilot Study (HTXDLYLAVGE)

University of Pennsylvania

Status: Enrolling

Conditions: Hemothorax; Traumatic

Treatments: Procedure: Serial Lavage and Drainage; Device: CLR Irrigator; Device: Percutaneous 14Fr Chest Tube; Device: 28 Fr Open Chest Tube

Study type: Interventional

Funder types: Other

Identifiers

NCT06937450

855480

Details and patient eligibility

About

This HTX treatment study evaluates the effects of chest tube size and the benefits of daily irrigations on acute HTX. 20 acutely injured but stable trauma patients requiring a chest tube for HTX will be enrolled. Patients will be assigned a 28Fr or 14 Fr chest tube with serial lavage and drainage. The endpoints will be HTX volume (by CT scan), complications, additional interventions, hospital length of stay, chest tube duration, provider feedback, and patient-reported outcomes.

Full description

This hemothorax (HTX) treatment study will evaluate the effects of chest tube size and daily lavage on HTX management outcomes. A total of 20 stable trauma patients requiring a chest tube for HTX will be recruited and consented. These patients will then undergo either 28Fr or 14Fr chest tube placement, depending on the preference of the treatment team at the time of placement. The study will include 10 patients with each type of chest tube (28Fr and 14Fr). Daily lavage will then be performed at 24h and 48h post-placement. Patients will be compared to historical control patients from the trauma registry who received either 28Fr or 14Fr chest tube placement followed by an initial lavage only. The primary endpoint will be the need for additional interventions such as tPA, additional chest tubes, thoracoscopic surgery (VATS), or thoracotomy. Secondary endpoints will include X-ray appearance at 72 hours, volume of HTX on CT at 72 hours, procedural complications, development of empyema (safety endpoint), development of delayed bleeding (safety endpoint), hospital length of stay, chest tube duration, provider feedback, and patient-reported outcomes.

Enrollment: 20 estimated patients

Sex: All

Ages: 15+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Able to provide consent for the research study
2. More than 15 years of age
3. Presence of acute traumatic HTX or HTX-PTX diagnosed on chest CT scan within 24 hours of injury and clinical indication for drainage (hemothorax of moderate or large size greater then 300 mL)
4. Hemodynamic stability (heart rate 120 beats per minute; systolic blood pressure 90 mmHg)
5. Bilateral or unilateral hemothorax of greater than 300 mL HTX by Mergo Formula from chest CT
6. Able to complete the entire study including randomization, tube placement, lavages and final CT Scan.

Exclusion criteria

1. Less than 15 years of Age
2. Prisoner
3. Pregnant due to the risk of CT scans
4. HTX or HTX-PTX not requiring drainage or drainage performed prior to randomization/enrollment
5. Patients undergoing operative intervention (i.e. thoracotomy) as initial management of hemothorax (6) Persistent hemodynamic instability after initial resuscitation and CT imaging

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: Single Blind

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20 participants in 2 patient groups

Open 28 Fr Tube Thoracostomy with Daily Lavage and Drainage

Experimental group

Description:

Open Tube Thoracostomy with Daily Lavage and Drainage

Treatment:

Device: 28 Fr Open Chest Tube

Device: CLR Irrigator

Procedure: Serial Lavage and Drainage

Percutaneous 14-Fr Catheter with Daily Lavage and Drainage

Experimental group

Description:

Percutaneous 14-Fr Catheter with Daily Lavage and Drainage

Treatment:

Device: Percutaneous 14Fr Chest Tube

Device: CLR Irrigator

Procedure: Serial Lavage and Drainage