The Effects of Peep and Tidal Volume on Oxidative Stress in Cardiopulmonary Bypass Surgery
2019年9月23日 更新者:Yavuz Orak、Kahramanmaras Sutcu Imam University
The Effect of PEEP and Tidal Volume on Thiol / Disulphide and Other Oxidative Stress Parameters in Cardio Pulmonary Bypass Surgery
Although cardio-pulmonary bypass surgery (CPBS) is a routine procedure worldwide, patient morbidity and mortality are still high due to postoperative negative complications.Inflammatory response and systemic oxidative stress have been reported to be directly related to this practice.Mechanisms explaining this condition have been described as being related to several events that occur during the cardiopulmonary bypass (CPBS), where blood is exposed to non-physiological surfaces, surgical trauma, ischemia-reperfusion, and changes in body temperature.In addition, CPB induces atelectasis and affects the structure of the bronchoalveolar tree.Prolongation of atelectasis may facilitate proinflammatory cytokine production by macrophages.One of the most damaging consequences of all these events is the formation of reactive oxygen species (ROS) and radicals originating from various cellular and enzymatic sources such as myocardial cells, activated neutrophils.ROS has toxic effects on cellular structures including lipids, proteins and nucleic acids.Oxidative reaction damages cellular function and may increase perioperative or postoperative complications after CPBS.Total antioxidant status (TAS), total oxidant status (TOS) and oxidative stress index (OSI) reflect the redox balance between oxidation and antioxidation.TAS measurement is an indication of the activity of all antioxidants and TOS is an indicator of ROS.OSI is a measure of the ratio of TOS to TAS and the level of Oxidative Stress (OS).The contribution of various mechanisms to oxidant-antioxidant balance during on-pump coronary artery bypass grafting (ONCABG) has not yet been fully evaluated.
The investigator's aim in this study is to investigate the effect of lung protective mechanism (Tidal Volum, PEEP) on oxidative stress parameters such as TAS, TOS, Thiol / Disulphide, Catalase, Glutathione Peroxidase, MDA (Melanil Dialdehyde) in cardio pulmonary bypass surgery
研究概览
详细说明
The study will be performed on patients who accept cardiopulmonary by-pass surgery, the conscious openness to participate in the study.Age, sex, body mass index (BMI), smoking habits, diagnosis, additional diseases, drugs used, surgery, intervention, anesthetic agents used in induction and dyspepsia, peroperative supportive treatments, left ventricular ejection fraction, post operative blood and TDP amount CPB (cardiopulmonary bypass) time (min), Cross clamp time (min), cardioplegia amount and type, analgesic name and dose made, duration of operation, name of postoperative and perioperative support treatments , perioperative and post operative intake and urine output,postoperative extubation time, intensive care day of hospitalization, day of hospitalization will be recorded.The study was planned in 3 groups.Group 1 mechanical ventilator closed group (mechanical ventilator off) FiO2; 50%, Flow: 2 L / min.
2 Group Tidal Volume 3-4ml / kg (TV), FIO2 50%, Flow: 2L / min, Frequency; 10-12 applied group.
3. Group Tidal Volume 3-4 ml / kg, PEEP: 5 cm H2O pressure, FIO2 50%, Flow: 2 L / min, Frequency:Planned to be the 10-12 applied group.Pre-operative, operative (After the cross clamp is removed) and postoperative (postoperative 24th hour) blood will be collected from patients participating in the study.Thiol / Disulphide, MDA, TAS, TOS, Catalase and Glutathione Peroxidase will be studied.
All patients should be premedicated with 0.1 mg / kg midazolam.Fentanyl (5-8 μg / kg), and rocuronium (0.5 mg / kg) will be used for induction of anesthesia.
During anesthesia, 2% sevoflurane will be used.Arterial cannula to be inserted.Central venous catheter and urinary catheter will be placed.
3 - 5 mg / heparin and cardioplegia will be applied.The active clotting time (ACT) will be kept above 400.Heparin 1: to be neutralized with 1.3% of the Protamine.In the postoperative period, all patients will be transferred to the intensive care unit.
研究类型
观察性的
注册 (实际的)
60
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
-
-
Onikişubat
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Kahramanmaraş、Onikişubat、火鸡、251/A 46040
- Kahramanmaraş Sütçü İmam University Faculty of Medicine
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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 80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
概率样本
研究人群
Patients who will be cardiopulmonary by-pass surgery and volunteer to participate in the study will be included in the study.
描述
Inclusion Criteria
- Patients who will be cardiopulmonary by-pass surgery and volunteer to participate in the study will be included in the study.
- Between 18-80 years
Exclusion Criteria:
- Patients requiring acute coronary syndrome and emergency cardiovascular surgery,
- Patients who have had myocardial infarction within the past month
- Recurrent cardiovascular surgery
- Off-pump coronary artery bypass surgery (OPCAB)
- Patients with chronic inflammatory disease (rheumatoid arthritis, malignancy, psoriasis, etc.), autoimmune disease, immunocompromised patients
- Patients with chronic renal failure, liver disease, active infection
- Patients older than 80 years and smaller than 18 years
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 |
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Group 1
1.Mechanical ventilator closed group (Mechanical ventilator off)
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Group 2
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Group 3
1. PEEP: 5 cm H2O basınç,
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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 |
---|---|---|
Oxidative stress markers
大体时间:Change from baseline before operation (preoperative),peroperative,24 hours after surgery,
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To evaluate the impact on the circulating levels of Catalase ü/ml,Glutathione Peroxidase ü/ml, Malondialdehyde nmol/ ml, Thiol Disulfide,TAS, TOS
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Change from baseline before operation (preoperative),peroperative,24 hours after surgery,
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
supportive care
大体时间:used during surgery and during the first 24 hours after surgery
|
Dopamine, Dobutamine,Gliserol Trinitrat, Adrenalin, Noradrenaline levels
|
used during surgery and during the first 24 hours after surgery
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blood and fresh frozen plasma (FFP)
大体时间:used during surgery and during the first 24 hours after surgery
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blood and fresh frozen plasma (FFP) quantities
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used during surgery and during the first 24 hours after surgery
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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 (实际的)
2018年8月1日
初级完成 (实际的)
2019年3月1日
研究完成 (实际的)
2019年3月10日
研究注册日期
首次提交
2018年7月17日
首先提交符合 QC 标准的
2018年7月25日
首次发布 (实际的)
2018年7月26日
研究记录更新
最后更新发布 (实际的)
2019年9月24日
上次提交的符合 QC 标准的更新
2019年9月23日
最后验证
2019年9月1日
更多信息
与本研究相关的术语
其他研究编号
- 2018/10-12
药物和器械信息、研究文件
研究美国 FDA 监管的药品
不
研究美国 FDA 监管的设备产品
不
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