Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| CLR Medical | UNKNOWN |
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Open 28 Fr Tube Thoracostomy with Daily Lavage and Drainage | Experimental | Open Tube Thoracostomy with Daily Lavage and Drainage |
|
| Percutaneous 14-Fr Catheter with Daily Lavage and Drainage | Experimental | Percutaneous 14-Fr Catheter with Daily Lavage and Drainage |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CLR Irrigator | Device | All enrolled patients will have their hemothorax treated with a CLR device that allows for easy suction and irrigation through indwelling catheters, |
|
| Measure | Description | Time Frame |
|---|---|---|
| Remaining Hemothorax Volume at 72 hours | Assessed by CT and Mergo Formula | 72 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients requiring intervention for retained hemothorax (excluding those who require intervention for other treatment) | All interventions focused on resolving any remaining hemothorax | Through hospital discharge or 30 days |
| Patient Tolerability - Numerical Rating Scale Insertion Perception Experience |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jeremy W Cannon, MD | Contact | 215-66-27320 | jeremy.cannon@pennmedicine.upenn.edu | |
| Phillp Kemp Bohan, MD | Contact | 267-909-3573 | Phillip.Kempbohn@Pennmedicine.upenn.edu |
| Name | Affiliation | Role |
|---|---|---|
| Jeremy Cannon, MD | University of Pennsylvania | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Penn Presbyterian Medical Center | Recruiting | Philadelphia | Pennsylvania | 19104 | United States |
There is no plan to share Individual Participant Data.
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D006491 | Hemothorax |
| ID | Term |
|---|---|
| D010995 | Pleural Diseases |
| D012140 | Respiratory Tract Diseases |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
Not provided
Not provided
| ID | Term |
|---|---|
| D004322 | Drainage |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D013514 | Surgical Procedures, Operative |
Not provided
Not provided
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.
Not provided
Not provided
Not provided
| Serial Lavage and Drainage | Procedure | The current protocol is to do a singular lavage and drainage, this study will investigate the benefits of daily lavage. |
|
| 28 Fr Open Chest Tube | Device | Patients will have a standard 28 Fr open chest tube or a percutaneous 14Fr chest tube placed. |
|
| Percutaneous 14Fr Chest Tube | Device | Patients will have a standard 28 Fr open chest tube, or a percutaneous 14Fr chest tube placed. |
|
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? |
| 1 hour, 24 hours, 48 hours |
| Patient Tolerability - Insertion Perception Experience (IPE) Perception Experience (IPE) | Patient perception of the chest tube insertion procedure.
| 1 hour |
| Ease of CLR System Use - Industry-Standard System Usability Scale (SUS) | By physician who used the CLR Irrigator System. 5-point Likert scale from strongly disagree (low) to strongly agree (high). | 1 hour, 24 hours, 48 hours |
| Chest Tube Placement Duration | Length of time the chest tube remained in the patient | Through discharge or 30 days |
| Length of hospital stay | Length of hospital stay | Through discharge or 30 days |
| Aggregate Hospital Charges for Patient Stay | Estimated cost of patient care at hospital | Through discharge or 30 days |
| D013568 |
| Pathological Conditions, Signs and Symptoms |