Penn Presbyterian Medical Center
Philadelphia, Pennsylvania, 19104, United States
Location status: Recruiting
NCT Number: NCT06937450
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.
Interested in participating?
Request Info15 year and older
All sexes
Interventional
Not applicable
Philadelphia, Pennsylvania, 19104, United States
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
All enrolled patients will have their hemothorax treated with a CLR device that allows for easy suction and irrigation through indwelling catheters,
The current protocol is to do a singular lavage and drainage, this study will investigate the benefits of daily lavage.
Patients will have a standard 28 Fr open chest tube or a percutaneous 14Fr chest tube placed.
Patients will have a standard 28 Fr open chest tube, or a percutaneous 14Fr chest tube placed.
Time frame: 72 hours
Assessed by CT and Mergo Formula
Time frame: Through hospital discharge or 30 days
All interventions focused on resolving any remaining hemothorax
Time frame: 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?
Time frame: 1 hour
Patient perception of the chest tube insertion procedure.
Time frame: 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).
Time frame: Through discharge or 30 days
Length of time the chest tube remained in the patient
Time frame: Through discharge or 30 days
Length of hospital stay
Time frame: Through discharge or 30 days
Estimated cost of patient care at hospital
Contact information is provided by the study sponsor or research team.
Jeremy W Cannon, MD
CONTACT
Phillp Kemp Bohan, MD
CONTACT
University of Pennsylvania
Other
Traumatic Hemothorax Treatment With 14-Fr Pigtail Catheters or Large Bore (~28Fr) Chest Tubes With Daily Irrigation: A Pilot Single-Arm Intervention Study
Acronym: HTXDLYLAVGE
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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