Pilot Evaluation of Closed Loop Ventilation and Oxygen Controller
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 主要终点
- " not acceptable " zone of ventilation
研究概览
简要总结
The study compares automated settings (Intellivent) with protocolized settings of the ventilator after cardiac surgery. The settings concern the respiratory rate, the inspiratory and expiratory pressure and FiO2. The aim of the study is to demonstrate that automated settings are feasible and safe.
The study design is a randomized controled study. 30 patients will be ventilated with automated mode and 30 patients with protocolized settings after cardiac surgery.
The hypothesis is that the automated mode allows a safer ventilation with better maintain of the patient in predefined optimal zone of ventilation.
详细描述
Aim: feasibility and safety study = evaluation of the possibility for a fully automated ventilator to safely manage the ventilation and oxygenation after cardiac surgery
Hypothesis:
Intellivent will maintain the patient with " optimal ventilation " better than during usual management with a minimal number of interventions
Monocentric: IUCPQ, Hôpital Laval, Québec Randomized controlled safety study, unblinded Patients after elective cardiac surgery Two arms Intellivent (fully automatic ventilation) Protocolized ventilation 4 hours study 60 patients planned to be included Primary outcome: number of episodes in the " not acceptable " zone of ventilation and duration
Secondary outcome:
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
- None
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •Unexpected surgical procedure
- •Major complication during surgery
- •Early extubation expected (< 1 hour)
- •Broncho-pleural fistula
- •Study ventilator not available
结局指标
主要结局
" not acceptable " zone of ventilation
时间窗: During the 4 hours of the protocol
Number of episodes, duration and percentage of time in the " not acceptable " zone of ventilation as pre-defined
次要结局
未报告次要终点
研究者
François Lellouche
Professeur
Laval University