Study to Determine if Using Ventilation During Open Heart Surgery Improves Lung Outcomes (PEEP)
Effect of Continuous Mechanical Ventilation During Cardiopulmonary Bypass on The Lung Mechanics: A Prospective Evaluation
研究概览
详细说明
This is a prospective, randomized, blinded study with a control group. The study group will receive mechanical ventilatory support during CBB, which consists of a preset/predetermined tidal volume, respiratory rate, positive pressure at the end of expiration and FIO2. The control group will receive CPB without additional mechanical ventilatory support during surgery, which at present is the standard of care.
The difference between the study and the control group will occur during the time the heart is arrested and the lungs, under present standard of care, are no longer ventilated. It is at this point in time that those in the study group will continue to receive ventilation, intermittent positive pressure ventilation, while their heart is arrested. The subjects will have their lungs ventilated six times per minute with a tidal volume equal to 7-10 milliliters per kilogram. This range, when combined with a consistent PEEP of 5cm of water pressure, will allow for the peak inspiratory pressure to be maintained at or below 40cm of water pressure. In addition, the FIO2 will remain consistent at the same level that was needed to maintain the pulse oximetry at 94% as well as the end-tidal CO2 at 35mmHg. The values mentioned for this study have been chosen based on not only investigator preference, but also on what is considered "minimally necessary" to prevent atelectasis. Multiple studies have been done utilizing PEEP at 5 and 10 cm of water pressure. With the exception of the potential for mechanical ventilation during the CBP, the care of the subject, regardless of the group randomized into, will be the same. We will in all other aspects continue to utilize the current standard of care.
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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Wisconsin
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Green Bay、Wisconsin、美国、54311
- Aurora BayCare Medical Center
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参与标准
资格标准
适合学习的年龄
- 孩子
- 成人
- 年长者
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- any patient of any gender, any age with known coronary artery disease that will undergo elective Coronary Artery Bypass Grafting (CABG) and will require CPB as part of his/her operative technique.
Exclusion Criteria:
- documented ejection fraction (either by echocardiogram or by cardiac catheterization) equal to or below 20%
- patients with cardiac valvular disease
- patients with a spirometry measurement that demonstrates an FEV1/FVC ratio below 60%
- patients with chronic renal failure who require dialysis or
- those who have experienced an allergic reaction to anesthesia in the past
- patients with a history of lung infiltrate on chest X-ray prior to surgery or a history of asthma
- Women who are pregnant are excluded
学习计划
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:三倍
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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无干预:Control
half of the study subjects will receive standard of care during their open heart surgery.
|
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实验性的:Treatment
half of the study subjects will receive the prescribed ventilatory support during open heart surgery.
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Those in the treatment group will receive ventilation, intermittent positive pressure ventilation, while their heart is arrested.
The subjects will have their lungs ventilated six times per minute with a tidal volume equal to 7-10 milliliters per kilogram.
This range, when combined with a consistent PEEP of 5cm of water pressure, will allow for the peak inspiratory pressure to be maintained at or below 40cm of water pressure.
In addition, the FIO2 will remain consistent at the same level that was needed to maintain the pulse oximetry at 94% as well as the end-tidal CO2 at 35mmHg.
|
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 |
|---|---|---|
|
Post-surgical lung function, compliance, tissue oxygenation, and radiographic changes indicative of atelectasis.
大体时间:During in-patient stay
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Determination if ventilation during surgery improves post-surgical lung function, compliance, tissue oxygenation, and radiographic changes indicative of atelectasis.
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During in-patient stay
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合作者和调查者
调查人员
- 首席研究员:Raul Mendoza-Ayala, MD、Aurora Health Care
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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