Impact of a Nocturnal Pressure Controlled Ventilation on Mechanical Ventilation Weaning Duration in Patients With Chronic Obstructive Respiratory Diseases REVENTIL 2
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- The percentage of ventilation weaning at Day 4
研究概览
简要总结
The weaning of mechanical ventilation is difficult period. This period is particularly difficult for patient with obstructive chronic respiratory disease and a long mechanical ventilation is associated with an increased risk of infectious complication, cardiac dysfunction, muscular weakness or barotromatism. No guideline is available on the ventilator mode to use during the night. In weaning period, some studies have demonstrated that nocturnal control ventilation during the weaning period improved the quality and the quantity of sleep. The hypothesis is that use of nocturnal controlled mechanical ventilation could decrease the weaning period duration and the ventilation weaning failure because of a sleep improvement.
The main objective is to compare mechanical ventilation weaning period duration according to the nocturnal ventilator mode (pressure controlled ventilation versus pressure support ventilation) in patients with an obstructive respiratory disease. A secondary objective is to evaluate the rate of weaning failure after the first extubation according to the nocturnal ventilator mode and to evaluate the sleep during the weaning period according to the nocturnal ventilator mode.
详细描述
All patients with weaning criteria, spontaneous breathing test will be done. If patient is able to have spontaneous ventilation with maximum of 16 cm of H2O of pressure support, he could be included in the study. The nocturnal ventilation mode will be randomised between pressure controlled ventilation and pressure support ventilation with the same pressure support than during the day. We will follow the quality and quantity of sleep with continue polysomnography. Indeed, patients in ICU could sleep during the night but too during the day. We will compare the duration of the weaning period between the two arms.
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 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient with invasive mechanical ventilation (with B840 ventilator)
- •Patient with ventilation weaning criteria
- •Patient able to support during the day pressure support ventilation with pressure support lower than 19 cm of H2O.
- •Patient with all mechanical ventilation weaning criteria for the first trial of spontaneous ventilation.
- •Age > 18 years
排除标准
- •Patient with central apnoea syndrome
- •Patient with narcolepsy
- •Patient with metabolic encephalopathy.
研究组 & 干预措施
Nocturnal controlled pressure control ventilation
use of an inspiratory pressure of 20 cm of H2O and an respiratory frequency chosen to stop all spontaneous breathing activity during the night
干预措施: Nocturnal controlled pressure control ventilation (Procedure)
Nocturnal pressure support ventilation
Use of a pressure support level identical during the night to the pressure support level at the end of the day.
干预措施: Pressure support ventilation (Procedure)
结局指标
主要结局
The percentage of ventilation weaning at Day 4
时间窗: at 4 day
次要结局
未报告次要终点
