Traumatic Hemothorax Drainage and Daily Lavage

Официальное название

Traumatic Hemothorax Treatment With 14-Fr Pigtail Catheters or Large Bore (~28Fr) Chest Tubes With Daily Irrigation: A Pilot Single-Arm Intervention Study

Обзор

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.

Подробное описание

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.

Вмешательства

• Устройство CLR Irrigator
  All enrolled patients will have their hemothorax treated with a CLR device that allows for easy suction and irrigation through indwelling catheters,
• Процедура Serial Lavage and Drainage
  The current protocol is to do a singular lavage and drainage, this study will investigate the benefits of daily lavage.
• Устройство 28 Fr Open Chest Tube
  Patients will have a standard 28 Fr open chest tube or a percutaneous 14Fr chest tube placed.
• Устройство Percutaneous 14Fr Chest Tube
  Patients will have a standard 28 Fr open chest tube, or a percutaneous 14Fr chest tube placed.

Первичные конечные точки

• Remaining Hemothorax Volume at 72 hours [Срок оценки: 72 hours]

Вторичные конечные точки (7)

• Number of patients requiring intervention for retained hemothorax (excluding those who require intervention for other treatment) [Срок оценки: Through hospital discharge or 30 days]
• Patient Tolerability - Numerical Rating Scale Insertion Perception Experience [Срок оценки: 1 hour, 24 hours, 48 hours]
• Patient Tolerability - Insertion Perception Experience (IPE) Perception Experience (IPE) [Срок оценки: 1 hour]
• Ease of CLR System Use - Industry-Standard System Usability Scale (SUS) [Срок оценки: 1 hour, 24 hours, 48 hours]
• Chest Tube Placement Duration [Срок оценки: Through discharge or 30 days]
• Length of hospital stay [Срок оценки: Through discharge or 30 days]
• Aggregate Hospital Charges for Patient Stay [Срок оценки: Through discharge or 30 days]

Критерии участия

Критерии включения

• Able to provide consent for the research study
• More than 15 years of age
• 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)
• Hemodynamic stability (heart rate 120 beats per minute; systolic blood pressure 90 mmHg)
• Bilateral or unilateral hemothorax of greater than 300 mL HTX by Mergo Formula from chest CT
• Able to complete the entire study including randomization, tube placement, lavages and final CT Scan.

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Одна группа

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Penn Presbyterian Medical Center — Philadelphia

Идентификаторы

NCT: NCT06937450 · 855480

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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