Low Tidal MEChanical Ventilation Against NO Ventilation During Cardiopulmonary Bypass Heart Surgery : a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,502
- 试验地点
- 2
- 主要终点
- All-cause mortality or early respiratory failure or Late respiratory failure or Ventilator acquired pneumonia and early pneumonia
研究概览
简要总结
BACKGROUND. Postoperative pulmonary complications are a leading cause of morbidity and mortality after cardiac surgery. To this date, there are no recommendations regarding mechanical ventilation associated with cardiopulmonary bypass (CPB) during the surgery and anesthesiologists perform either no ventilation (noV) at all during CPB or maintain a low-tidal volume ventilation (LTV). Indirect evidence points towards better pulmonary outcomes when LTV is performed but no proper prospective trial with large inclusion of all types of cardiac surgery has been published.
DESIGN. The MECANO trial is a single-center, double-blind, randomized controlled trial comparing two mechanical ventilation strategies, noV and LTV, during cardiac surgery with CPB. 1500 patients will be included for whom planned cardiac surgery with CPB is performed. They will be randomized between noV and LTV, on a 1:1 ratio. The noV group will receive no ventilation during CPB. The LTV group will receive 5 acts/minute with a tidal volume of 3 mL/kg and positive end-expiratory pressure of 5 cmH2O. Primary endpoint will be composite of overall death, early respiratory failure defined as PaO2/FiO2 ratio <200 mmHg at one-hour after arrival in the ICU, heavy oxygenation support (defined as a patient requiring either non-invasive ventilation, mechanical ventilation or high flow oxygen) at 2 days after arrival in the ICU or ventilator acquired pneumoniae defined by Center of Disease Control. Lung recruitment manoeuvers will be performed for noV and LTV groups, at the end of surgery and at the arrival in ICU with an insufflation at +30 cmH20 during 5 seconds. Secondary endpoints are those composing the primary endpoint with the addition of pneumothorax, CPB duration, quantity of postoperative bleeding, red blood cells transfusions, revision surgery requirements, length of stay in the ICU and in the hospital and total hospitalization costs. Patients will be followed until hospital discharge.
SUMMARY. The MECANO trial compares a no-ventilation to a low-tidal volume strategy for mechanical ventilation during cardiac surgery with CPB, regarding a primary composite outcome including death, respiratory failure and pneumoniae.
详细描述
BACKGROUND. Ventilator-acquired pneumonia (VAP) are a common postoperative complication and account for a large part of post-cardiac surgery morbidity and mortality. Incidence of VAP depends on numerous factors, some of which are pulmonary collapsus and atelectasis during cardiopulmonary bypass, a lowering of bronchial arterial blood flow and a systemic inflammation response syndrome during and after cardiopulmonary bypass (CPB).
On the one hand, CPB allows blood oxygenation during cardiac surgery, regardless of heartbeat and oscillations, allowing surgeon to operate without disturbance.
On the other hand, postoperative pulmonary complications appear to be more frequent when no mechanical ventilation is maintained while under CPB.
Recent meta-analysis found oxygenation improvement after the weaning from CPB when low-tidal-volume (LTV) ventilation was maintained or after lung recruitment maneuvers (LRM), as compared to when there was no ventilation (noV). Furthermore, maintaining mechanical ventilation would reduce the inflammation response and tissue damage. The design of these studies did not provide with clinical hard endpoints such as respiratory complications, death or length of stay, hence, an unquestionable standardized strategy of lung protection during CPB has not been evidenced at this time and there are no scientific recommendations on whether mechanical ventilation has to be maintained during cardiac surgery or not, notably between low-tidal volume ventilation (LTV) and no-ventilation (noV).
The investigators aim to prove superiority of LTV over noV strategy during CPB in cardiac surgery, in order to decrease postoperative respiratory complications.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
Patients are ventilated or not during the time they are sedated, so they are blind to their study arm.
Anesthesiologists perform mechanical ventilation or not during cardiopulmonary bypass and log per-operative data (such as number of insufflations) on a separate leaflet of the eCRF. Investigators (cardiologists and critical care specialists) are not aware of the treatment arm as it is performed during surgery.
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
- •more than 18 years old
- •ability to provide an informed consent
- •planned surgery
- •surgical intervention with cardio-pulmonary bypass, aortic clamp and cardioplegia.
排除标准
- •impossibility to wean CPB at the end of cardiac surgery
研究组 & 干预措施
Low tidal volume ventilation (LTV arm)
During cardiopulmonary bypass, mechanical ventilation is maintained with 5 acts/minute, tidal volume = 3 ml/kg (ideal body weight) with positive end-expiratory pressure = 5 cmH2O
干预措施: Low tidal volume ventilation (LTV arm) (Procedure)
Low tidal volume ventilation (LTV arm)
During cardiopulmonary bypass, mechanical ventilation is maintained with 5 acts/minute, tidal volume = 3 ml/kg (ideal body weight) with positive end-expiratory pressure = 5 cmH2O
干预措施: Lung recruitment manoeuver (Procedure)
No ventilation (noV arm)
No mechanical ventilation during cardiopulmonary bypass.
干预措施: No ventilation (noV arm) (Procedure)
No ventilation (noV arm)
No mechanical ventilation during cardiopulmonary bypass.
干预措施: Lung recruitment manoeuver (Procedure)
结局指标
主要结局
All-cause mortality or early respiratory failure or Late respiratory failure or Ventilator acquired pneumonia and early pneumonia
时间窗: From date of randomization until the date of first documented event or date of death from any cause, whichever came first, assessed up to 24 months.
Composite outcome with all-cause in-hospital mortality, early respiratory failure defined as PaO2/FiO2 ratio \<200 at the first hour after transfer in ICU after surgery, late respiratory failure defined as heavy oxygenation support (non-invasive ventilation, high flow oxygen or mechanical ventilation) two days after surgery and pneumonia (early or ventilator acquired) defined by Center of Disease Control (CDC) criteria (2016 guidelines).
次要结局
- Pneumonia (early or ventilator-acquired)(From date of randomization until the date of first documented event, assessed up to 24 months.)
- Length of stay in the hospital(Assessed at the end of hospitalization, through study completion, assessed up to 24 months.)
- Early respiratory failure(Assessed at one hour after transfer in postoperative ICU)
- Length of stay in the ICU(Assessed at the end of hospitalization, through study completion, assessed up to 24 months.)
- All-cause in-hospital mortality(From date of randomization until date of death from any cause, assessed up to 24 months.)
- heavy oxygenation support(Assessed 2 days after surgery)
- Cost of hospitalization(Assessed at the end of hospitalization, through study completion, assessed up to 24 months.)