Hemodynamic Changes During One Lung Ventilation in Non-intubated Vedio-assisted Thoracoscopic Operations
2014年12月3日 更新者:National Taiwan University Hospital
Hemodynamic Changes and Fluid Responsiveness During One Lung Ventilation: Comparison in Non-intubated and Intubated Vedio-assisted Thoracoscopic Operations
Non-intubated thoracoscopic surgery has been proved as an adequate alternative for management of many lung conditions such as pneumothorax , lung volume reduction, pulmonary metastasectomy, removal of lung nodules, segmentectomy and lobectomy.
However, the hemodynamic changes during one lung ventilation have not been fully investigated.
The goals of this study are to compare the changes of hemodynamics (including blood pressure, heart rate, cardiac output, pulse pressure variation, fluid responsiveness) during one lung ventilation between conventional intubated and non-intubated vedio-assisted thoracoscopic (VATS) operations.
研究概览
地位
完全的
条件
详细说明
Non-intubated vedio-assisted thoracoscopic (VATS) is proved safely performed as well as traditional intubated VATS.
However, the differences of hemodynamic changes and fluid responsiveness during one lung ventilation(OLV) between these two groups were rarely reported.
For complete lung collapse, spontaneous negative pressure respiration must be well maintained on non-intubated VATS.
In comparison, positive pressure ventilation on dependent lung was applied during OLV in intubated VATS.
This study planned to compared the changes of hemodynamics (including blood pressure, heart rate, cardiac output) during OLV between groups.
As functional hemodynamic monitoring (FloTrac system) was mostly utilized with positive pressure ventilation, the applicability of FloTrac in non- intubated VATS was also testified.
In this study, we also measure the fluid responsiveness by FloTrac system with rapid infusion (within 10 minutes) of 10 mL/kg crystalloid fluid.
We planned to compare the changes on cardiac output and the fluid responsiveness during OLV between these two groups.
研究类型
观察性的
注册 (实际的)
71
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
-
-
-
Taipei、台湾、100
- National Taiwan University Hospital
-
-
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
20年 至 70年 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
取样方法
非概率样本
研究人群
patients scheduled to receive video-assisted thoracoscopic (VATS) operations with one lung ventilation(OLV)
Inclusion criteria:
- age over 20 y/o, less than 70 y/o
- scheduled to receive VATS operations with OLV
Exclusion:
- previous thoracic surgery
- cardiac disease ( including arrhythmias, congestive heart failure, coronary cardiac disease, etc.)
- pulmonary disease
描述
Inclusion criteria:
- age over 20 y/o, less than 70 y/o
- scheduled to receive VATS operations with OLV
Exclusion:
- previous thoracic surgery
- cardiac disease ( including arrhythmias, congestive heart failure, coronary cardiac disease, etc.)
- pulmonary disease
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
队列和干预
团体/队列 |
---|
non-intubated
VATS, non-intubated
|
intubated
VATS, intubated
|
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 |
---|---|---|
cardiac output after one lung ventilation
大体时间:10-15 minutes
|
record the stroke volume and cardiac output during two lung ventilation till 15 minutes after one lung ventilation
|
10-15 minutes
|
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。
调查人员
- 首席研究员:Ya-Jung Cheng、Department of Anesthesiology, National Taiwan University Hospital
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
2014年5月1日
初级完成 (实际的)
2014年11月1日
研究完成 (实际的)
2014年12月1日
研究注册日期
首次提交
2014年4月21日
首先提交符合 QC 标准的
2014年4月23日
首次发布 (估计)
2014年4月25日
研究记录更新
最后更新发布 (估计)
2014年12月4日
上次提交的符合 QC 标准的更新
2014年12月3日
最后验证
2014年12月1日
更多信息
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.