Ventilation During Cardiopulmonary Bypass (CPB) for Cardiac Surgery - Effect on Pulmonary Atelectasis Post-operatively, a Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Time to complete study in operating room and ICU
研究概览
简要总结
During most types of heart surgery cardiopulmonary bypass (CPB) is used. CPB enables blood to be directed away from the heart and the lungs and pumped through the body while the heart is not beating. Surgery on the heart easier when it is not beating and bloodless area. Generally during CPB the lungs do not need to be ventilated, as no blood is flowing through the lungs and the body received oxygen from a machine (oxygenator) attached to the CPB pump.
In this study we are investigating the difference in lung collapse after heart surgery in patient who did have their lungs ventilated during CPB, compared to patients who did not have their lungs ventilated during CPB. We will use lung ultrasound scans to determine the degree of lung collapse at various time periods before and after the heart surgery. We will also investigate if ventilation during CPB will affect: a.) the rate of lung infection or pneumonia after the operation b.) the time it takes for a patient to have the breathing tube removed in the intensive care unit after the operation c.) the time for a patient to be discharged home from the hospital d.) the concentration of oxygen in the blood after the operation.
详细描述
Objective and Hypothesis:
To determine if continued mechanical ventilation (low tidal volume ventilation) during cardiopulmonary bypass (CPB) in adult patients undergoing elective cardiac surgery will reduce the degree of pulmonary atelectasis post-operatively, when compared to controls not ventilated during CPB.
The degree of pulmonary atelectasis will be assessed and quantified using non-invasive lung ultrasound (LUS) imaging.
We will conduct a preliminary observational study (pilot study) to assess the feasibility of this study. The pilot will be conducted on 40 patients, all of whom will be non-ventilated during CPB. The specific feasibility questions we would like to determine are: 1) the degree of atelectasis that can be demonstrated by LUS on patients that are not ventilated while on CPB, 2) the time needed to complete a LUS in the operating room (OR) and in the intensive care unit (ICU) and whether this will be efficient and possible given the busy operating room schedule, 3) to help determine the optimal time to scan patients to show the maximal degree of atelectasis, and 4) to help estimate the number of patients we will need to show a difference in atelectasis in the definitive study.
Primary hypothesis: low tidal volume ventilation during CPB for adult cardiac surgery reduces the amount of pulmonary atelectasis compared to controls not ventilated during CPB.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult elective coronary artery bypass surgery requiring CPB
排除标准
- •Cardiac surgery without CPB
- •Complex cardiac surgery (valve repairs, combined bypass and valve repairs etc.)
- •Emergency cardiac surgery
- •Fibrotic lung disease
- •Previous lung volume reduction surgery (CXR will be assessed pre-operatively)
- •Massive blood product transfusion intra- and/or post-operatively will exclude patient
- •Patients enrolled in other studies eg. SIRS study (steroid use)
结局指标
主要结局
Time to complete study in operating room and ICU
时间窗: 3 months
To assess feasibility of LUS investigation in pre-operative and post-operative patients (time required to complete study in operating room and ICU, practicality of performing LUS in a busy environment). The LUS investigations are reported to be a fast and reliable investigation. However, few data are available about its use in a perioperative setting.
次要结局
- Assess the evolution of LUS(3 months)
- Determine sample size for future Randomized Control Trial(3 months)