Effect of Perioperative Lung Protective Strategies on the Occurrence of Postoperative Pulmonary Complications in Patients Undergoing Lumbar Spinal Surgery in the Prone Position
2016年6月13日 更新者：Yonsei University
Postoperative pulmonary complications are main cause of overall perioperative morbidity and mortality in the patients following general anesthesia.
A protective ventilation strategy refers to the use of low VT (in the range of 4-8 ml/kg of the predicted body weight) with positive end-expiratory pressure (PEEP), with or without recruitment maneuver.
Protective ventilation has been considered the optimal practice in patients suffering from the acute respiratory distress syndrome (ARDS).
However, few human studies have assessed how to ventilate healthy lungs in patients undergoing general anesthesia, especially in prone position.
Prior studies reported that in the patients undergoing major abdominal surgery in supine position, intraoperative lung protective ventilator settings had the potential to protect against pulmonary complications.
Therefore, the investigators planned this study to better specify the effect of intraoperative protective ventilation in surgical patients in the prone position.
研究概览
研究类型
介入性
注册 (实际的)
78
阶段
- 第四阶段
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
-
-
-
Seoul、大韩民国、120-752
- Department of Anesthesiology and Pain Medicine
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
19年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- the patient undergoing elective lumbar spine surgery of two hours or more in the prone position
- the age: 19 yrs and older
- the patients had a preoperative risk index for pulmonary complications of more than 2.
Exclusion Criteria:
- Patients with altered mental status or increased intracranial pressure
- Body mass index more than 35 kg/m2
- Patients with persistent hemodynamic instability or intractable shock
- Severe cardiac disease defined as New York Heart Association class III or IV or acute coronary syndrome or persistent ventricular tachyarrhythmias
- Recent history of invasive ventilation (within two weeks)
- Recent history of pneumonia, ALI/ARDS or sepsis (within two weeks)
- History of pulmonary resection, emphysema or chronic obstructive pulmonary disease (COPD)
- Repeated systemic corticosteroid therapy for acute exacerbations of COPD or asthma
- Recent immunosuppressive medication defined as need of chemotherapy or radiation therapy (within two months)
- History of neuromuscular disease
- Emergency operation
- Patient refusal
- Pregnancy
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：预防
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Conventional ventilation
Conventional ventilation with TV of 10 mL/kg predicted body weight (PBW) without positive end-expiratory pressure (PEEP) during the surgery under general anesthesia
|
Conventional ventilation with TV of 10 mL/kg predicted body weight (PBW) without positive end-expiratory pressure (PEEP) during the surgery under general anesthesia
|
|
有源比较器：Protective lung ventilation
Protective lung ventilation with TV of 6 mL/kg PBW, PEEP of 6 cmH2O and recruitment maneuver during the surgery under general anesthesia
|
Protective lung ventilation with TV of 6 mL/kg PBW, PEEP of 6 cmH2O and recruitment maneuver during the surgery under general anesthesia
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
forced vital capacity (FVC)
大体时间：3 days after the spine surgery
|
The changes in the pulmonary functional tests [forced vital capacity (FVC) and forced expiratory volume in 1 second (FEV1)].Pulmonary functional tests were performed at the bedside by using a spirometer while the patients in a seated, comfortable position.
|
3 days after the spine surgery
|
|
forced expiratory volume in 1 second (FEV1)
大体时间：3 days after the spine surgery
|
The changes in the pulmonary functional tests [forced vital capacity (FVC) and forced expiratory volume in 1 second (FEV1)].Pulmonary functional tests were performed at the bedside by using a spirometer while the patients in a seated, comfortable position.
|
3 days after the spine surgery
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2015年2月1日
初级完成 (实际的)
2016年1月1日
研究完成 (实际的)
2016年6月1日
研究注册日期
首次提交
2015年2月10日
首先提交符合 QC 标准的
2015年2月22日
首次发布 (估计)
2015年2月27日
研究记录更新
最后更新发布 (估计)
2016年6月15日
上次提交的符合 QC 标准的更新
2016年6月13日
最后验证
2016年6月1日
更多信息
与本研究相关的术语
其他研究编号
- 4-2014-0955
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.