A Prospective Comparison of the Efficacy and Safety of Intellectual Mode of Ventilation (Intellivent-ASV) With Conventional Modes in Cardiac Surgery Patients With Body Mass Index >35
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Percentage of patients with tidal volume in optimal, suboptimal, unoptimal zone
研究概览
简要总结
compare effects of intellectual mode (in our case it will be Intellivent - ASV -) with conventional ventilation modes after uncomplicated cardiac surgery in patients with body mass index >35
详细描述
The study includes the comparison of two methods of invasive respiratory support ventilation( conventional ventilation modes and automatic IntelliventASV mode (a fully automated, or closed-loop, ventilation mode that consists of pressure-controlled ventilation or pressure support ventilation depending on a patient's respiratory activity. In fully automated ventilation mode, tidal volume, pressure levels (including PEEP), minute ventilation, and the oxygen fraction in inspired air are controlled solely by the ventilator) after uncomplicated cardiac surgery). It assumes 30 randomized patients:15 patients in two study groups male and female aged 30 to 70 years of age inclusive, with BMI > 35 kg/m2. The study will be randomized, single-center, prospective.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 30 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •• Age from 30 years to 70 years inclusive
- •elective cardiac surgery which included bypass, valve and ascending aortic surgery,
- •a body mass index of > 35 kg/m2,
- •postoperative treatment with mechanical ventilation,
- •informed consent
排除标准
- •• GFI <30 ml/min before surgery, serum aspartate and alanine transaminase concentration greater than 80 U/l before surgery, left ventricular ejection fraction less than 30% before surgery.
- •Postoperative exclusion criteria:
- •chest tube drainage greater than 3 ml/kg/h,
- •reoperation,
- •myocardial infarction,
- •need for high-dose inotropes or vasopressors or intraaortic balloon pump,
- •presence of a bronchopleural fistula and refractory hypoxemia with an arterial oxygen tension to fractional inspired oxygen concentration ratio less than 150 mmHg,
- •perioperative anaphylactic reaction,
- •seizures,
- •agitation
研究组 & 干预措施
conventional ventilation mode
respiratory support after cardiac surgery. Vt < 6 ml/kg PBW, driving pressure < 13 cmH2O
干预措施: respiratory support (Procedure)
intelectual mode - Intelivent ASV
closed loop mode of mechanical ventilation Vt < 6 ml/kg PBW, driving pressure < 13 cmH2O
干预措施: respiratory support (Procedure)
结局指标
主要结局
Percentage of patients with tidal volume in optimal, suboptimal, unoptimal zone
时间窗: During the first 8 hours, since admission on the ICU with the start of the respiratory support
Number of Participants during mechanical ventilation with Tidal volume in optimal zone \< 6 ml/kg/Predicted Body Weight ; Tidal volume in suboptimal zone 6-8 ml/kg/Predicted Body Weight Tidal volume in unoptimal zone \>8 ml/kg/Predicted Body Weight
次要结局
- the physician's workload(24 hours)