Hemothorax; Traumatic
Conditions
Brief summary
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.
Detailed 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.
Interventions
DEVICECLR Irrigator
All enrolled patients will have their hemothorax treated with a CLR device that allows for easy suction and irrigation through indwelling catheters,
PROCEDURESerial Lavage and Drainage
The current protocol is to do a singular lavage and drainage, this study will investigate the benefits of daily lavage.
DEVICE28 Fr Open Chest Tube
Patients will have a standard 28 Fr open chest tube or a percutaneous 14Fr chest tube placed.
DEVICEPercutaneous 14Fr Chest Tube
Patients will have a standard 28 Fr open chest tube, or a percutaneous 14Fr chest tube placed.
Sponsors
University of Pennsylvania
CLR Medical
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Intervention model description
This is a single arm interventional pilot study comparing groups of trauma hemothorax-diagnosed patients. There will be 2 treatment groups and 2 historical control groups.
Eligibility
Sex/Gender
ALL
Age
15 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Remaining Hemothorax Volume at 72 hours | 72 hours | Assessed by CT and Mergo Formula |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of patients requiring intervention for retained hemothorax (excluding those who require intervention for other treatment) | Through hospital discharge or 30 days | All interventions focused on resolving any remaining hemothorax |
| Patient Tolerability - Numerical Rating Scale Insertion Perception Experience | 1 hour, 24 hours, 48 hours | Patient perception of the drainage and lavage procedure ranging from 1 (tolerable) to 5 (worst experience of my life). Did this Drainage and Lavage procedure resolve, lessen or worsen the patient's symptoms? |
| Patient Tolerability - Insertion Perception Experience (IPE) Perception Experience (IPE) | 1 hour | Patient perception of the chest tube insertion procedure. 1. = It was okay, I can tolerate it, I can do it again. 2. = It was okay, but I don't want to go through this again. 3. = It was a bad experience for me. 4. = It was a worse experience for me. 5. = It was the worst experience of my life! |
| Ease of CLR System Use - Industry-Standard System Usability Scale (SUS) | 1 hour, 24 hours, 48 hours | By physician who used the CLR Irrigator System. 5-point Likert scale from strongly disagree (low) to strongly agree (high). |
| Chest Tube Placement Duration | Through discharge or 30 days | Length of time the chest tube remained in the patient |
| Length of hospital stay | Through discharge or 30 days | Length of hospital stay |
| Aggregate Hospital Charges for Patient Stay | Through discharge or 30 days | Estimated cost of patient care at hospital |
Countries
United States
Contacts
CONTACTJeremy W Cannon, MD
CONTACTPhillp Kemp Bohan, MD
PRINCIPAL_INVESTIGATORJeremy Cannon, MD
University of Pennsylvania
Outcome results
None listed