POStoperative INTELLiVENT-adaptive Support VEntilation in Cardiac Surgery Patients II (POSITiVE II) - a Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 328
- 试验地点
- 2
- 主要终点
- Quality of ventilation
研究概览
简要总结
'POStoperative INTELLiVENT-adaptive support VEntilation in cardiac surgery patients II (POSITiVE II) is an investigator-initiated, international, multicenter, parallel, randomized clinical trial in patients after cardiac surgery.
详细描述
To compare INTELLiVENT-ASV with conventional ventilation with respect to (i.) quality of ventilation; and (ii.) ICU nursing staff workload in an international cohort of participants receiving postoperative ventilation after cardiac surgery. This study will also determine the effects of INTELLiVENT-ASV on clinical outcomes, including (iii.) duration of postoperative ventilation and (iv.) length of stay in ICU.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 120 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •aged > 18 years of age;
- •scheduled for elective cardiac surgery; and
- •expected to receive postoperative ventilation in the ICU for > 2 hours.
排除标准
- •any emergency or semi-elective surgery (precluding informed written consent);
- •any surgery other than CABG, valve replacement or repair, or a combination (i.e., patients planned for surgery for congenital heart disease, or scheduled for heart transplantation are excluded);
- •enrolled in another interventional trail;
- •no written informed consent obtained;
- •history of recent pneumectomy or lobectomy;
- •history of COPD with oxygen at home;
- •body mass index > 35;
- •preoperative forced expiratory volume in the first second (FeV1)/forced vital capacity (VC) < 50% (if available);
- •preoperative arterial oxygen partial pressure (PaO2) < 60 mm Hg (at room air);
- •preoperative arterial carbon dioxide partial pressure (PaCO2) > 50 mm Hg;
- •preoperative left ventricular ejection fraction < 30% (if available);
- •preoperative systolic pulmonary artery pressure > 60 mm Hg (if available);
- •preoperative left ventricular mechanical support, e.g., Impella®; or
- •preoperative use of veno-venous or veno-arterial extracorporeal support
- •At the end of surgery, patients are additionally excluded if a patient:
- •cannot be weaned from the extracorporeal support; or
- •unexpectedly needs implementation of an assist device
结局指标
主要结局
Quality of ventilation
时间窗: During the first 2 hours, since admission on the ICU with the start of the intervention ventilation mode.
The primary outcome is quality of ventilation, which is the proportion of time spent in three predefined and previously used zones of ventilation in the first 2 hours of postoperative ventilation. * An optimal zone = Tidal volume (TV) = 4-8 ml/kg of the predicted body weight (PBW) with an EtCO2 = 30-45mmHg, a plateau pressure = \<31cmH2O and SpO2 = 93-98%. * An acceptable zone = TV = 8-12 ml/kg of PBW with an EtCO2 = 25-30 or 45-50mmHg, a plateau pressure = 31-35 cmH2O and SpO2 = 85-93% or \>98%. * An unacceptable zone = TV \>12 ml/kg of PBW or an EtCO2 = \<25 or \>50mmHg, plateau pressure \>35 cmH2O or SpO2 = \<85%.
次要结局
- Proportion of breath spent in zones of ventilation(Up to 6 hours of mechanical ventilation time)
- ICU nursing staff workload(24 hours)
- Patient-ventilator asynchrony(Up to 6 hours of mechanical ventilation time)
- ICU length of stay(From date of ICU admission until the date of ICU discharge, assessed up to 30 days)
- Hospital length of stay(From date of hospital admission until the date of hospital discharge, assessed up to 30 days)
- Duration of postoperative ventilation(8 hours or until extubation)
- Mortality(28-day)
研究者
Prof. Dr. Edda Tschernko
Principal Investigator
Medical University of Vienna