Comparison of Computer-Driven Protocolized Weaning With Physician-Directed Weaning in Surgical Intensive Care Unit (ICU) Patients
试验速览
- 阶段
- 不适用
- 状态
- 暂停
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- weaning duration
研究概览
简要总结
The purpose of this study was to determine whether computer-driven protocolized weaning is superior to physician-directed non-protocolized weaning in over-24-hours-ventilated surgical intensive care unit (ICU) patients. The main hypothesis was that weaning duration differs between both methods. Secondary hypotheses were that reintubation rate, duration of mechanical ventilation, intensive care unit (ICU) length of stay and workload for physicians and nurses differ between both methods.
详细描述
Since long-term mechanical ventilation is affiliated with a bunch of complications, weaning affected patients from ventilation as soon as possible is a crucial point. In this context automated computerized systems have become a torchbearer. These systems are expected to expedite the weaning process, reduce the duration of mechanical ventilation and ICU length of stay of a given patient in comparison to conventional physician-directed weaning. A multicenter randomized trial by Lellouche et al supported these theories, using a computer-driven system to regulate Pressure Support Ventilation (PSV). This system is now commercially available as SmartCare/PS (Draeger Medical AG & Co. KG, Luebeck, Germany).
The purpose of the study on hand was to find out whether the results reported before could be repeated in a broad, surgical ICU patient group. Study design was chosen similar. In addition we investigated the workload for physicians and nurses in both study arms which has not been conducted before.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •mechanical ventilation > 24 hours
- •intubation OR tracheostomy
- •informed consent
- •35 - 200 kg bodyweight (77,2 - 440,9 lb)
- •Ramsay-Score < 3
- •spontaneous breathing at a PEEP of < 10 cm H2O
- •sufficient arterial oxygenation (paO2 > 55 mmHg or SaO2 > 90%)
- •haemodynamic stability (< 5 µg/kg/min Dopamine)
- •body temperature (rectal) max. 39 °C / 102.2 °F
- •hemoglobin > 7 g/dl
- •pH > 7,2
排除标准
- 未提供
研究组 & 干预措施
AW
Patients received computer-driven protocolized weaning (= Automated Weaning)
干预措施: SmartCare/PS (Automated Weaning) (Device)
CW
Patients received physician-directed non-protocolized weaning (= Conventional Weaning)
干预措施: Conventional weaning (Procedure)
结局指标
主要结局
weaning duration
时间窗: measured in days
次要结局
- reintubation rate(expressed as a percentage)