Effect of Low Tidal Volume Ventilation in Improving Oxygenation and Thus Reducing Acute Lung Injury in the Cardiac Surgical Patient
2017年3月15日 更新者:Sugantha Sundar、Beth Israel Deaconess Medical Center
We propose that as low tidal volume ventilation has proven to be beneficial in patients with established ARDS it may have a role in preventing the onset of acute lung injury in the cardiac surgical population.
Institution of low tidal volume ventilation in the operating room may reduce the release of the cytokines and interleukins that have been known to contribute to the development of acute lung injury.
In this study, we propose that the institution of low tidal volume ventilation in the operating room will reduce the incidence of acute lung injury.
Measurement of PaO2 to FiO2 ratio twenty four and forty eight hours post operatively will help determine if there is a difference in oxygenation between the two groups.
Chest X-ray findings, time to extubation and length of ICU stay will also determine if there is a role for low tidal volume ventilation in the operating room.
We will also attempt to establish a causative mechanism by measuring plasma levels of cytokines known to be associated with the development of ARDS.
研究概览
详细说明
Methods- A single center randomized controlled trial was undertaken in 149 patients comparing ventilation with 6 ml/kg TV to ventilation with 10 ml/kg TV in patients undergoing elective cardiac surgery.
Study ventilator settings were applied immediately after induction of anesthesia and continued throughout surgery and the subsequent Intensive Care Unit stay.
The primary endpoint of the study was time to extubation.
Secondary endpoints included the proportion of patients extubated at 6 hours, indices of lung mechanics and gas exchange as well as patient clinical outcomes.
研究类型
介入性
注册 (实际的)
150
阶段
- 不适用
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
-
-
Massachusetts
-
Boston、Massachusetts、美国、02215
- Beth Israel Deaconess Medical Center
-
-
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
18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:
- Patients coming in for cardiac surgical procedures will be recruited into the study.
- Both men and women will be recruited into the study.
- All patients over the age of 18 will be recruited into the study.
- Discussion between the surgeon and the primary investigator will happen prior to approaching the patient to obtain informed consent.
Exclusion Criteria:
- Patients with preexisting respiratory failure and active infection will be excluded from the study.
- Patients undergoing one lung ventilation during surgery will be excluded from the study.
- Patients undergoing emergency cardiac surgery will be excluded from the study.
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:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的:Low tidal volume arm
|
|
|
有源比较器:Conventional tidal volume arm
|
研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
|---|---|
|
Time to extubation
大体时间:the time patient was extubated in the ICU
|
the time patient was extubated in the ICU
|
次要结果测量
结果测量 |
大体时间 |
|---|---|
|
Oxygenation at 4 hours, 8 hours, 12 hours and 24 hours post surgery.
大体时间:measurement of blood gas at 4, 8 , 12 and 24 hours post surgery
|
measurement of blood gas at 4, 8 , 12 and 24 hours post 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。
调查人员
- 研究主任:Daniel Talmor, MD、Beth Israel Deaconess Medical Center
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
2007年10月1日
初级完成 (实际的)
2009年10月1日
研究完成 (实际的)
2011年1月1日
研究注册日期
首次提交
2007年9月30日
首先提交符合 QC 标准的
2007年10月1日
首次发布 (估计)
2007年10月2日
研究记录更新
最后更新发布 (实际的)
2017年3月17日
上次提交的符合 QC 标准的更新
2017年3月15日
最后验证
2017年3月1日
更多信息
与本研究相关的术语
关键字
- 心脏手术
- 急性肺损伤
- The incidence of ARDS after elective cardiac surgery is 1-3%
- The impairment of lung function and oxygenation may occur in 20-80% of patients undergoing surgery.
- The purpose of this study is to assess the efficacy of low tidal volume ventilation.
- Reducing interleukin and cytokine production may prevent or reduce the incidence of acute lung injury.
其他研究编号
- 2007P000113
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.