Shanghai Jiao Tong University Affiliated Sixth People's Hospital
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- conversion to tracheal intubation
研究概览
简要总结
Tracheal intubation and general anesthesia has been considered a safe and conventional routine methodology for thoracic surgery, include multiple rib fratcure. However,adverse effects such as sore throat, pain, hoarseness, and respiratory complications are common after that. In this study, we decide to perform surgical stabiliazation of rib fractures by paravertebral block surgical stabiliazation of rib fractures under awake or appropriate sedation without endotracheal intubation keeping spontaneous respiration to investigate its safety and feasibility.
详细描述
Rib fracture is common in the world,especially in chest trauma. Conservative treatment is used to it for many years but the effect is not well because of continuous pain caused by the dislocation of broken rib. Surgical stabiliazation of rib fractures can relieve the pain rapidly and help patient recover to work early. This kind of surgery is constantly conducted with tracheal intubation and general anesthesia. However,adverse effects such as sore throat, pain, hoarseness, and respiratory complications are common after that. So we think perform surgical stabiliazation of rib fractures under awake or appropriate sedation without endotracheal intubation keeping spontaneous respiration to investigate its safety and feasibility.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Simple rib fracutures patients
- •No other truama
- •Unilatieral rib fractures
- •Total number of rib fractures is less than 5
- •At least one rib dislocation
- •18-80 years old
- •ASA grade I-II
- •Preoperative arterial partial pressure of oxygen > 60mmhg
- •Partial pressure of carbon dioxide < 50mmhg
排除标准
- •Difficult airway
- •History of esophageal reflux
- •Myasthenia gravis
- •Coagulation disorders
- •Gastrointestinal ulcer
- •Gastrointestinal bleeding
- •Anesthetic drugs allergy history
- •Chronic obstructive pulmonary disease
- •Pregnant women.
结局指标
主要结局
conversion to tracheal intubation
时间窗: during surgery
index of consciousness(IOC): If the scale low zhan 40 or high than 60, it need intubation
pain score
时间窗: 24 hours after operation
Numerical Rating Scale(NRS): 0-10 is used to represent different degrees of pain, 0 is painless and 10 is severe pain. The grading criteria of pain were: 0: no pain; 1-3: mild pain; 4-6: moderate pain; 7-10: severe pain
次要结局
- operation time(during surgery)
- blood loss(during surgery)
- days of stay hospital(from the date of hospitalization to the date of leave hospital,assessed up to 100 months)
- costs of stay hospital(from the date of hospitalization to the date of leave hospital,assessed up to 100 months)
- PONV score(24 hours after operation)
研究者
Weigang Zhao
Clinical Professor
Shanghai Jiao Tong University Affiliated Sixth People's Hospital