Neural Pressure Support, a Randomized Crossover Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- Patient-ventilator asynchronies
研究概览
简要总结
In this study patients who are intubated and on ventilator for more than 24h will be ventilated at three different level of support in Pressure Support and Neural Pressure Support to study patient-ventilator synchrony and muscle unloading.
详细描述
This study is an interventional randomized crossover study in intubated and mechanically ventilated patients for more than 24h. Eligible patients from whom informed consent is obtained and Pes and Edi catheter are successfully positioned are enrolled in the study. Patients will be ventilated in Pressure Support and Neural Pressure Support at three different level of assist (baseline, 50% and 150% of baseline respectively) in randomized order. Ventilator curves will be recorded and bloodgas obtained at the end of each study step, each lasting 20min.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients intubated for more than 24 hours in the weaning phase from the ventilator.
排除标准
- •bleeding disorders (PK INR>1,5 or APTT>50s or platelet count <50000/µL)
- •unstable circulation (requiring high vasopressor dose, for example Noradrenalin >0,2µg/kg/min)
- •severe lung disease (PFI ≤ 13,3 kPa)
- •fever> 38,5°C
- •pregnancy.
研究组 & 干预措施
Neural Pressure Support
Patients will be ventilated in Pressure Support and Neural Pressure Support at 3 different levels of support in randomized order
干预措施: Neural Pressure Support (mode of mechanical ventilation) (Device)
结局指标
主要结局
Patient-ventilator asynchronies
时间窗: 20 minutes ventilatory traces recording
quantification of asynchronies by the use of the Edi catheter
次要结局
- respiratory muscle unloading(20 minutes ventilatory traces recording)
研究者
Francesca Campoccia Jalde
Francesca Campoccia Jalde, MD, PhD
Karolinska Institutet