Evaluating chest tube size and daily lavage for traumatic hemothorax treatment
Traumatic Hemothorax Treatment With 14-Fr Pigtail Catheters or Large Bore (~28Fr) Chest Tubes With Daily Irrigation: A Pilot Single-Arm Intervention Study
This study is testing whether using different sizes of chest tubes and daily washing can improve recovery for patients with bleeding in the chest after a trauma.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 15 Years and up |
| Sex | All |
| Sponsor | University of Pennsylvania Academic / other |
| Locations | 1 site (Philadelphia, Pennsylvania) |
| Trial ID | NCT06937450 on ClinicalTrials.gov |
What this trial studies
This pilot study investigates the impact of different chest tube sizes and the effects of daily irrigation on patients with acute traumatic hemothorax. A total of 20 stable trauma patients requiring chest tube drainage will be enrolled and assigned to receive either a 28Fr or 14Fr chest tube. Daily lavage will be performed at 24 and 48 hours post-placement, and outcomes will be compared to historical controls. The study aims to assess the need for additional interventions, complications, and patient-reported outcomes.
Who should consider this trial
Good fit: Ideal candidates are stable trauma patients over 15 years old with acute traumatic hemothorax requiring drainage.
Not a fit: Patients with hemothorax not requiring drainage or those undergoing immediate surgical intervention may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve management strategies for traumatic hemothorax, potentially reducing complications and hospital stays.
How similar studies have performed: While similar approaches have been explored, this specific combination of chest tube size and daily lavage is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Philadelphia, Pennsylvania
- Penn Presbyterian Medical Center — Philadelphia, Pennsylvania, United States (Recruiting)
Study contacts
- Principal investigator: Jeremy Cannon, MD — University of Pennsylvania
- Study coordinator: Jeremy W Cannon, MD
- Email: jeremy.cannon@pennmedicine.upenn.edu
- Phone: 215-66-27320
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.