Use of a Novel Chest Tube Insertion Device for Urgent Thoracostomy in an Emergency Department Setting
试验速览
- 阶段
- 3 期
- 入组人数
- 54
- 主要终点
- Patient report of pain
研究概览
简要总结
Tube thoracostomy is commonly performed in the emergency department for patients suffering from traumatic hemo- or pneumo-thorax. The procedure involves the use of a scalpel incision at the skin followed by blunt dissection through tissue, penetration into the thoracic cavity, dilation of a tract for tube placement, exploration of the thoracic cavity with a gloved finger, and finally insertion of a sterile tube into the intrathoracic space. The procedure is considered extremely painful despite the routine provision of systemic analgesics and local anesthetics.
Cadaver and animal studies have demonstrated the use of the Reactor chest tube device, a squeeze-activated thoracostomy trochar with placement of a clear sheath for chest tube insertion, to decrease procedure time, incision size, and blood loss. Case series and observational reports suggest lower rates of procedural complication and failure as well as increased patient satisfaction due to pain reduction.
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
- •Subjects age ≥ 18 years old
- •Attending physician determination of need for urgent tube thoracostomy for treatment of traumatic pneumothorax, hemothorax, or hemopneumothorax.
- •Hemodynamically stable
排除标准
- •Pregnant patients
- •Need for emergency thoracostomy
- •Hemodynamic instability
- •Respiratory distress
研究组 & 干预措施
Traditional
干预措施: Tube thoracostomy (Procedure)
Reactor Device
干预措施: Reactor Device (Device)
结局指标
主要结局
Patient report of pain
时间窗: During procedure
As measured on a 100mm VAS
次要结局
- Procedure time(During procedure)
研究者
Richard Pescatore
Director of Clinical Research
Crozer-Keystone Health System
