A Cross-over Study to Compare Two Different Tracheal Cuff Pressure Monitoring Devices in a Pediatric Intensive Care Unit
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 44
- 试验地点
- 2
- 主要终点
- Percentage of time spend with over or under-inflation of the tracheal cuff
研究概览
简要总结
Despite the expert recommendation about rigorous monitoring of tracheal cuff pressure using a continuous or intermittent technique, cuff underinflation and overinflation are common increasing the risk of microinhalation and tracheal ischemia. All these complications are associated with high morbidity and mortality in ICU.
详细描述
In this study, the investigators will compare the duration of the period of under-inflation and over-inflation between electronic (VBM©) and pneumatic (Nosten©) devices (continuous monitoring of tracheal cuff pressure), in critically intubated children. This study aims to determine the effectiveness of the electronic device in the continuous monitoring of tracheal cuff pressure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 2 Days 至 5 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Infants and children more than 2 days after birth at term and less than 5 years of age
- •Patient intubated in the PICU with a cuffed endotracheal tube
- •Predicted duration of mechanical ventilation > or = 24-hours
- •Signed informed consent
排除标准
- •Intubated with an uncuffed endotracheal tube
- •Children admitted to the PICU with a previous tracheostomy
- •Preterm children or infants less than 2 days post-term
- •Patient under block neuromuscular treatment
- •Patient enrolled in another trial that might influence this study results
结局指标
主要结局
Percentage of time spend with over or under-inflation of the tracheal cuff
时间窗: 12 hours
Continuous recording of cuff pressure will be performed during the two 12-hours periods (electronic and pneumatic devices). The period was speared by a time of wash-out of 30 minutes
次要结局
- The response time to a significant variation in cuff pressure(12 hours)