跳至主要内容
临床试验/NCT03734471
NCT03734471Unknown3 期

Use of a Novel Chest Tube Insertion Device for Urgent Thoracostomy in an Emergency Department Setting

Crozer-Keystone Health System0 个研究点目标入组 54 人开始时间: 2019年1月1日最近更新:
适应症
干预措施

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

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

Active Comparator

干预措施: Tube thoracostomy (Procedure)

Reactor Device

Experimental

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Richard Pescatore

Director of Clinical Research

Crozer-Keystone Health System

相似试验