SUS-HPTX Trial: Suction vs Underwater Seal for HemoPneumoThoraX Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Chest tube duration
研究概览
简要总结
Traumatic pneumothorax and hemothorax are common consequences of chest injury, often requiring prompt tube thoracostomy to re-expand the lung and drain accumulated blood or air. Current practice varies widely regarding whether chest tubes should initially be placed to suction or to water seal, and prior studies have reported mixed findings. While suction may theoretically improve drainage and lung expansion, some studies suggest it may prolong air leaks and chest tube duration. Conversely, initial water seal has been associated with shorter tube duration without an increase in complications. The predecessor to this trial, the SEAL IT Trial, demonstrated that water seal reduced chest tube duration in patients with pneumothorax without an increase in complication, but excluded those with significant hemothorax. This single-center, randomized controlled trial (SUS-HPTX) will expand upon those findings by evaluating the effect of initial chest tube management strategy, suction versus water seal, in trauma patients with hemopneumothorax or hemothorax. Patients will be assigned to one of the two groups based on calendar month of enrollment, with clinicians able to adjust management as needed. The primary outcome is chest tube duration. Secondary outcomes include chest tube-related complications (e.g., empyema, pneumonia, re-accumulation of pneumothorax or hemothorax, need for additional procedures), hospital length of stay, readmissions, and mortality. Because both suction and water seal are accepted standards of care, the study involves minimal incremental risk. Findings will expand prior evidence and inform best practices for chest tube management in trauma
详细描述
Traumatic pneumothorax occurs in up to 20% of major trauma patients and is frequently accompanied by hemothorax, with concomitant hemothorax reported in up to 70% of cases. These injuries are typically managed with placement of a chest tube to evacuate air and blood from the pleural space, facilitate lung re-expansion, and prevent respiratory or hemodynamic compromise. Following placement, chest tubes are commonly managed using either continuous negative-pressure suction (typically -20 cm H₂O) or water seal alone. Although both methods are widely accepted as standard-of-care, substantial variation exists in clinical practice regarding the initial suction status of chest tubes, with decisions often driven by provider preference or institutional norms rather than high-quality evidence.
Suction theoretically promotes lung re-expansion by generating negative intrathoracic pressure; however, studies in postoperative thoracic surgery patients suggest that suction may prolong or exacerbate air leaks, potentially increasing chest tube duration. Prior trauma-focused studies evaluating suction versus water seal have produced conflicting results with respect to chest tube duration, pleural space complications, and hospital length of stay. The predecessor SEAL IT trial conducted at the study institution demonstrated that initial water seal management reduced chest tube duration in patients with traumatic pneumothorax without increasing complications; however, that study excluded patients with larger hemothoraces, leaving uncertainty regarding optimal initial management in patients with hemothorax or hemopneumothorax.
Given the limited and conflicting data in trauma patients with hemothorax or hemopneumothorax, further investigation is warranted to determine whether initial water seal management is noninferior or superior to suction in this population. This trial is designed to address this knowledge gap by evaluating whether initial placement of chest tubes to water seal decreases chest tube duration without increasing complications when compared with initial suction.
This trial is a single-center, non-blinded, clustered randomized controlled trial conducted at Vanderbilt University Medical Center. Adult trauma patients admitted to the trauma service who require placement of a chest tube (percutaneous or open) for treatment of traumatic hemothorax or hemopneumothorax are eligible for enrollment. Patients are excluded if they are younger than 18 years of age, are pregnant, are prisoners, or have had a chest tube placed prior to computed tomography imaging. Randomization is performed using a cluster-by-month design. During odd calendar months (January, March, May, July, September, and November), all enrolled patients will have their chest tubes placed to water seal initially. During even calendar months (February, April, June, August, October, and December), all enrolled patients will have their chest tubes placed to -20 cm H₂O suction initially. This design minimizes treatment contamination and facilitates enrollment in an emergent setting.
For patients randomized to the water seal group, the chest tube will be briefly placed to suction for one minute immediately following placement to evacuate residual air and blood, after which it will be transitioned to water seal. For patients randomized to the suction group, the chest tube will remain on -20 cm H₂O suction after placement. Aside from the initial suction status, all subsequent chest tube management decisions-including changes in suction status, imaging frequency, duration of tube placement, and criteria for removal-will be determined at the discretion of the treating clinical team, consistent with usual care. Any changes in suction status and the reasons for those changes will be documented.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Admitted to trauma service
- •Patient has hemothorax or hemopneumothorax requiring chest tube
排除标准
- •Less than 18 years old, pregnant, prisoner, chest tube placed prior to CT scan
研究组 & 干预措施
Odd months
干预措施: Water Seal (Other)
Even months
干预措施: Suction (Other)
结局指标
主要结局
Chest tube duration
时间窗: hours from placement of chest tube to removal of chest tube, on average 3 days
次要结局
未报告次要终点
研究者
Kelsey Evans
Acute Care Surgery Clinical Fellow
Vanderbilt University Medical Center
