Driving Pressure And Limitation of Expiratory Flow: Evaluation of Postoperative Pulmonary Complications in Elective Adult Cardiac Surgery.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Expiratory Flow Limitation
研究概览
简要总结
During general anesthesia, functional residual capacity (FRC) is reduced. If the FRC is lower than the minimum volume required to maintain the opening of the airways, there is a derecruitment of the lung parenchyma, leading to the phenomenon of expiratory flow limitation (EFL).
The Driving Pressure (DP) is the difference between the plateau pressure (Pplateau) and the Positive End-Expiratory Pressure (PEEP), and estimates the lung strain.
The incidence of EFL and the importance of DP are not known in adult cardiac surgery, so it's necessary a study to assess both. The primary end-point of the study is to evaluate the correlation of DP and EFL with PPCs in adult cardiac surgery. The secondary end-point of the study is to evaluate: the mechanical ventilation time, the length of ICU and hospital stay, the rehospitalization and mortality.
It will be a prospective, observational, non-pharmacological study. It will enroll 200 patients undergoing elective adult cardiac surgery.
详细描述
During general anesthesia, functional residual capacity (FRC) is reduced. If the FRC is lower than the minimum volume required to maintain the opening of the airways (closing capacity), there is a derecruitment of the lung parenchyma, leading to the phenomenon of expiratory flow limitation (EFL). Numerous factors contribute to the EFL, including hyperoxia, muscle paralysis, the increase of the volume of the interstitial fluids and the inflammatory response.
To establish the presence of EFL under general anesthesia, it was developed a test known as PEEP test. It is the sudden removal of 3 cm H2O to the value of positive end-expiratory pressure (PEEP test): in the EFL the subtraction of the expiratory pressure does not produce an increase of expiratory flow. The use of different modality of mechanical ventilation during cardiac surgery may impact on the incidence of EFL post CEC.
The Driving Pressure (DP) is the difference between the plateau pressure (Pplateau) and the Positive End-Expiratory Pressure (PEEP), and estimates the lung strain.
The primary end-point of the study will be:
- Evaluate the correlation of DP and EFL with PPCs in patients undergoing elective cardiac surgery performed with extracorporeal circulation.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age > 18 years old
- •Ability to provide an informed consent
- •Planned cardiac surgery with median sternotomy and bi-pulmonary ventilation
- •patients scheduled for adult elective cardiac surgery, performed with CPB and aortic cross-clamping.
排除标准
- •Patient refusal to provide informed consent
- •Emergency surgery
- •Cardiac surgery with TAVI/MitraClip
- •Planned thoracotomy with one lung ventilation
- •Patients with chronic kidney insufficiency (defined as dialysis)
- •Patients already intubated in the peri-operative period
- •Patients with pneumonia in the pre-operative period (30 days before surgery)
结局指标
主要结局
Expiratory Flow Limitation
时间窗: Through study completion, an average of 24 hours after surgery
Incidence of Driving Pressure
时间窗: Through study completion, an average of 24 hours after surgery
次要结局
- Postoperative pulmonary complication(Through study completion, an average of 7 days after surgery)
- ICU length of stay(Through study completion, an average of 24 hours after surgery)
- Hospital length of stay(Through study completion, an average of 7 days after surgery)
- Duration of mechanical ventilation(Through study completion, an average of 7 days after surgery)
- PaO2/ FiO2(Through study completion, an average of 24 hours after surgery)
- Mortality(Through study completion, an average of 7 days after surgery)
研究者
Elena Bignami
MD
Ospedale San Raffaele