Evaluation a New Ventilatory Modes: VARIABLE-PSV: a Randomized Controlled Cross-over Study: the " VARIABLE-PSV" Study
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Oxygenation in each ventilatory mode
研究概览
简要总结
Variable PSV is a new ventilatory mode which delivered a pressure support "variable" from 0 to 100% variation of the set PSV level.This study aimed to compare the ventilatory behavior, sleep quality and gas exchange between VARIABLE (or Noisy)-PSV and "standard" (or fixed)-PSV during the weaning phase of critically ill patients who required mechanical ventilation.
详细描述
Twenty patients will be enrolled. They will be ventilated withVARIABLE-PSV and STANDARD-PSV: for 24 h each in a randomized crossover order. The ventilatory parameters, ventilator/patient asynchrony, gas exchange effects, sleep quality and ventilatory comfort produced by the two ventilation modes will be compared. Before randomisation, a sequence of VARIABLE-PSV will be performed with different level of variation setting to better define the future behavior of the patient under this mode during the 24 h of Variable-PSV.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Participant)
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
- •ventilation planned for more than 48 h
- •patient alert and calm corresponding to a Richmond Agitation-Sedation Scale (RASS) between -2 and 0
- •Age > or equal 18
- •Surrogate decision maker's consent
排除标准
- •Clinical instability for any reason.
- •Life support withdrawal code
- •Patient under tutelage
- •Pregnancy
- •No French health insurance
研究组 & 干预措施
VARIABLE-PSV ventilatory mode
干预措施: VARIABLE-PSV ventilatory mode (Other)
STANDARD-PSV ventilatory mode
干预措施: STANDARD-PSV ventilatory mode (Other)
结局指标
主要结局
Oxygenation in each ventilatory mode
时间窗: after 24h of mechanical ventilation in each mode
We will performed arterial blood gases and oxygenation wil be evaluated by the PaO2/FiO2 ration.
次要结局
- Ventilatory comfort(during 24h in each mode)
- Feasibility(during the 24 hours)
- Patient/ventilator asynchronism(during the 24 hours)
- Ventilatory effects(during the 24 hours)
- Sleep quality(after the 24 hours)