A Randomized Controlled Trial Comparing a Fully Closed Loop Ventilation Mode (Intellivent ASV) With Pressure Controlled + Pressure Support Ventilation in COPD Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 88
- 试验地点
- 2
- 主要终点
- Duration of intubation
研究概览
简要总结
This study will evaluate the effect of a fully closed loop ventilation mode (Intellivent ASV) on the duration of ventilation compared to conventional modes in COPD patients.
详细描述
COPD patients often need invasive mechanical ventilation and due to the difficulties in the weaning of these patients, duration of mechanical ventilation can be relatively longer when compared with other ICU patients. Automated systems show promising results in shortening the weaning time in some patient groups. The aim of this study is to evaluate the effect of Intellivent-ASV with Quickwean function on the total duration of invasive mechanical ventilation as a primary outcome. Secondary outcomes are success rate and duration of weaning, ventilator free days at day 28 and intubation free days at day 28 (including NIV) when compared to conventional ventilation with t-piece weaning.
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
- Double (Participant, Outcomes Assessor)
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
- •COPD patients intubated and mechanically ventilated for less than 24 hours (Including patients who received NIV before intubation)
- •Age > 18 years
- •Written and/or informed consent
排除标准
- •Septic shock
- •Tracheostomy and/or home mechanical ventilation
- •Expected poor short term prognosis
- •Cardiac arrest with a poor neurological prognosis
- •Broncho-pleural fistula
结局指标
主要结局
Duration of intubation
时间窗: 24th month
Time from intubation until extubation
Duration of mechanical ventilation (NIV included)
时间窗: 24th month
Total time patient remains on mechanical ventilation support (invasive or noninvasive)
次要结局
- Weaning duration(24th month)
- Time spent on spontaneous ventilation(24th month)
- Number of manual settings(24th month)
- Number of blood gas analysis tests(24th month)
研究者
Cenk Kirakli, M.D.
Associate Professor, Pulmonary and Critical Care Medicine
Izmir Dr Suat Seren Chest Diseases and Surgery Education and Research Hospital