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临床试验/NCT06587906
NCT06587906招募中不适用

Postoperative Complications Following Skull Base Tumor Resection: an Observational Study

Beijing Tiantan Hospital1 个研究点 分布在 1 个国家目标入组 122 人开始时间: 2024年9月10日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
122
试验地点
1
主要终点
The incidence of postoperative pulmonary complications

研究概览

简要总结

The skull base tumor is located in the deep intracranial layer and is closely related to the brain stem and intracranial nerves. The incidence of postoperative complications after skull base tumor resection is high. Therefore, the perioperative management of skull base tumor resection is challenging.

详细描述

  1. Postoperative pulmonary complications (PPCs), always had a 11.2%-24.6% high incidence rate. Pulmonary ultrasound (LUS), as a non-invasive diagnostic tool, has high accuracy in diagnosing pulmonary complications. Compared to traditional chest X-ray examinations, pulmonary ultrasound can identify PPCs such as atelectasis and pneumothorax earlier, and it is also more accurate in diagnosing lung consolidation.With relevant literature postoperative PACU pulmonary ultrasound is used to predict the area under the PPC curve (AUC) of 0.64 in patients within 8 days after non cardiac major surgery. Through pulmonary ultrasound examination, doctors can identify high-risk patients with pulmonary complications early after surgery. In this observational study, investigators aimed to assess the occurrence of PPCs within 7 days after surgery and evaluate the accuracy of preoperative and postoperative lung ultrasound scores in predicting PPCs.
  2. Patients with skull base tumors often have a high risk of postoperative lower extremity venous thrombosis due to long operation time and many postoperative complications, such as long-term bed rest. If not treated in time, lower extremity venous thrombosis can cause disability, and severe cases can cause serious consequences such as pulmonary embolism due to thrombus detachment. In this observational study, investigators aimed to prospectively collect perioperative data and the occurrence of DVT.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

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

  • Age 18 and above
  • American Society of Anesthesiologists physical status I to III
  • Undergoing elective resection of skull base tumors
  • Obtaining written informed consent

排除标准

  • Heart failure, myocarditis, pericarditis, and cardiomyopathy
  • Myocardial ischemia less than 6 months old
  • Severe arrhythmia
  • Severe bradycardia (heart rate below 50 beats per minute)
  • Unable to complete preoperative cardiac assessment
  • Severe liver dysfunction (Child Pugh C-grade)
  • Severe lung diseases

结局指标

主要结局

The incidence of postoperative pulmonary complications

时间窗: Postoperative 7 days

The primary outcome was the incidence of a composite endpoint of postoperative pulmonary complicationswithin 7 days after surgery. Postoperative pulmonary complications was considered to have occurred if at least one postoperative pulmonary event was observed, such as the pneumonia, pleural effusion, respiratory failure, hypoxemia, pneumothorax, atelectasis of the lung, bronchospasm..Ultrasound scans were performed at 20 min before starting mechanical ventilation of the lungs (before intubation) and performed at 20 min after surgery (after extubation)

次要结局

  • The incidence of postoperative deep venous thrombosis(Postoperative 7 days)
  • Cardiac injury(Postoperative 7 days and 30 days)
  • Postoperative pain(Postoperative 2 days and 7 days)
  • Overall complications(Postoperative 7 days and 30 days)
  • Postoperative mortality rate(Postoperative 7 days and 30 days)

研究者

发起方
Beijing Tiantan Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Yuming Peng

Deputy chief of Department of Anesthesiology

Beijing Tiantan Hospital

研究点 (1)

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