Prospective Evaluation of 14F Thal Tube vs 28 French Chest Tube for Hemothorax and Use of Maximum Barrier Precautions
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 193
- 试验地点
- 2
- 主要终点
- Number of Participants With Retained Hemothorax Following Initial Chest Tube Placement Requiring Intervention
研究概览
简要总结
Traumatic hemothorax and hemopneumothorax are common diagnoses which are typically treated by placement of a chest tube. 28-32 Fr chest tubes have previously been shown equivalent to 36-40 Fr chest tubes for the non-emergent drainage of hemothorax. A smaller study has found 14 Fr pigtails had less pain than larger tubes but was not powered to compare outcomes. We seek to perform a prospective randomized trial that is adequately powered comparing efficacy of 14 Fr thal tubes to 28 Fr chest tubes for non-emergent drainage of hemothorax and hemopneumothorax. Additionally, we will employ maximal barrier precautions for all chest tube insertions and compare empyema rates to our historical controls.
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
- Single (Investigator)
盲法说明
Investigator masked to outcomes data.
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
- •The patient is admitted to the trauma service.
- •The patient has a hemothorax and/or or hemopneumothorax, requiring thoracostomy tube placement.
- •Thoracostomy tube placement is able to be performed or witnessed by an investigator listed on the study.
- •The patient has not had a chest tube in the past year.
- •The patient is >18 years of age.
- •In the event the patient is decisionally impaired, consent will be obtained from the individual's legally authorized representative (LAR) or from the individual's healthcare power of attorney (HPA).
- •In the instance of reversible impairment, initial consent would be obtained from the LAR/HPA and the patient will be approached for consent once he/she is deemed mentally competent by the care provider.
排除标准
- •The patient is incarcerated
- •The patient is known to be pregnant
- •The patient is < 18 years of age
- •The patient is hemodynamically unstable, requiring emergent chest tube placement (in <10 minutes from evaluation).
结局指标
主要结局
Number of Participants With Retained Hemothorax Following Initial Chest Tube Placement Requiring Intervention
时间窗: 90 days
Number of Participants with Retained hemothorax requiring an additional intervention, either video-assisted thoracoscopic surgery (VATS) or additional thoracostomy tube placement.
次要结局
- Number of Participants Stratified by Length of Hospitalization Stay(90 days)
- Change in Subjective Pain Scores From Baseline at 90 Days(90 days)
- Duration of Chest Tube Placement.(90 days)
- Hemodynamic Stability Post-insertion(90 days)
- Initial Drainage From Chest Tube at 5 Minutes(5 Minutes)
- Time to Radiographic Resolution of Pneumothorax/Hemothorax/Hemopneumothorax(90 days)
- Recurrent Pneumothorax/Hemothorax/Hemopneumothorax After Tube Removal(90 days)
- Tube Specific Complications: Air Leak, Tube Malposition, & Tube Migration(90 days)
- Readmission for Chest Tube Related Complications(90 days)