The Effects of Different Ventilator Strategies on Inflammation and Injury in Normal Lungs
2015年5月1日 更新者：University of Medicine and Dentistry of New Jersey
This research is being done to determine if there is a way the investigators can improve the techniques that they use to assist patients with their breathing during surgery.
The majority of surgeries require patients to concurrently undergo general anesthesia.
This usually includes a breathing tube and a machine that breathes for the patient during the duration of the surgery.
The doctors would like to investigate the effects of this type of anesthesia to healthy adult patients and whether they can improve the way they give general anesthesia to patients.
The investigators plan to ask approximately 200 patients to participate.
If the patients decide to participate in the study,some additions will be made to the standard anesthetic care they receive.
The patients will additionally be monitored for adequate oxygenation in their blood as well as level of inflammation in their blood and lungs.
The patients' breathing tube will be bathed with warm normal saline and suctioned twice during the operation.
When these procedures are done the patients will be asleep and not be aware of what is happening.
研究概览
详细说明
The ability to provide mechanical ventilation that will not injure and may protect normal lungs during major surgical procedures of long duration may improve postoperative outcomes and decrease morbidity and mortality.
The aim of the current study was to identify ventilator strategies that are less damaging to normal lungs.
The investigators plan to compare three ventilation strategies commonly utilized in the operating room in normal lungs.
One group will be ventilated with high tidal volume (15 mL/kg PBW) and low PEEP (3 cm H2O), another group ventilated with low tidal volume (6 mL/kg PBW) and low PEEP (3 cm H2O) and the final group ventilated with low tidal volume (6 mL/kg PBW) and high PEEP (10 cm H2O).
This study will show the effects of these commonly used methods of ventilation on pulmonary mechanics, systemic and pulmonary inflammatory markers and outcomes in patients with normal lungs undergoing surgery of long duration.
研究类型
介入性
注册 (实际的)
1
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
-
-
New Jersey
-
Newark、New Jersey、美国、07101
- UMDNJ/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
18年 至 65年 (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:
- Elective surgery under general anesthesia expected to take 4 hours or more positioned supine for surgery
Exclusion Criteria:
- Subjects who have HIV or who have had Radiation or chemotherapy for cancer
- Subjects undergoing surgery on chest or lings
- Subjects who have obstructive sleep apnea (OSA), asthma, tuberculosis, chronic obstructive 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
- 主要用途：治疗
- 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 |
|---|---|
|
有源比较器：1
High tidal volume (15mL/kg PBW0 with low PEEP (3cm H2O
|
Active Comparison of three different parameters of ventilator settings.
Results of arterial blood gases and cytokine levels.
|
|
有源比较器：2
Low tidal volume (6mL/kg PBW) and high PEEP (3cm H2O)
|
Active Comparison of three different parameters of ventilator settings.
Results of arterial blood gases and cytokine levels.
|
|
有源比较器：3
low tidal volume (6mL/kg PBW) and high PEEP (10cm H2O)
|
Active Comparison of three different parameters of ventilator settings.
Results of arterial blood gases and cytokine levels.
|
研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
|
cytokine levels in serum and bronchial aspirate
大体时间：during the operative procedure
|
during the operative procedure
|
次要结果测量
结果测量 |
大体时间 |
|---|---|
|
arterial blood gases
大体时间：during the operative procedure
|
during the operative procedure
|
|
subject post-operative outcome:mortality, pulmonary complications, major cardiac morbidity, LOS, readmission
大体时间：wothin 30 days of surgery
|
wothin 30 days of 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
- 首席研究员：Ellise Delphin, MD、Rutgers, the State University of New Jersey
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- Wrigge H, Zinserling J, Stuber F, von Spiegel T, Hering R, Wetegrove S, Hoeft A, Putensen C. Effects of mechanical ventilation on release of cytokines into systemic circulation in patients with normal pulmonary function. Anesthesiology. 2000 Dec;93(6):1413-7. doi: 10.1097/00000542-200012000-00012.
- Wrigge H, Uhlig U, Baumgarten G, Menzenbach J, Zinserling J, Ernst M, Dromann D, Welz A, Uhlig S, Putensen C. Mechanical ventilation strategies and inflammatory responses to cardiac surgery: a prospective randomized clinical trial. Intensive Care Med. 2005 Oct;31(10):1379-87. doi: 10.1007/s00134-005-2767-1. Epub 2005 Aug 17.
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
2009年3月1日
初级完成 (实际的)
2010年3月1日
研究完成 (实际的)
2010年3月1日
研究注册日期
首次提交
2009年10月21日
首先提交符合 QC 标准的
2009年10月28日
首次发布 (估计)
2009年10月29日
研究记录更新
最后更新发布 (估计)
2015年5月5日
上次提交的符合 QC 标准的更新
2015年5月1日
最后验证
2015年4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.