Impact of an Electronic Monitoring Device on Maintaining a Correct Elevation of Head of Bed for Mechanically-ventilated Patients in Intensive Care Unit
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 105
- 试验地点
- 2
- 主要终点
- proportion of time spent per day in semirecumbent position as defined by a head of bed inclination between 40° and 50°
研究概览
简要总结
Maintaining mechanically-ventilated patients in semi-recumbent position (defined by a head of bed inclination between 30° and 45°) would decrease the risk of pneumopathy occurrence in those patients. However, such a bed inclination frame is still difficult to maintain in day-to-day care.
The aim of the study is to evaluate the impact of an electronic monitoring device on the proportion of time spent per day in semi-recumbent position, as defined by a head of bed inclination between 40° and 50°, in mechanically-ventilated patients.
详细描述
Maintaining semi-recumbent position (defined by a head of bed inclination between 40° and 50°) is an international guidance to prevent ventilator-associated pneumopathy which is the main nosocomial infection in intensive care unit. However, maintaining such an inclination has been shown to be difficult in day-to-day care.
This could be improved by using an assistance device that would measure inclination of the head of bed in real time and trigger an alarm when the value order is not reached, hence allowing a quick readjustment if necessary.
The investigators want to evaluate en electronic monitoring device (EMD) that is removable and adjustable to all beds, which would allow a whole intensive care unit to be fully equipped at low cost.
Hypothesis : using an EMD could improve the proportion of time spent per day in semi-recumbent position (defined by a head of bed inclination between 40° and 50°) in mechanically-ventilated patients.
Primary objective : to evaluate the impact of an EMD with alarm on the proportion of time spent per day in semi-recumbent position, as defined by a head of bed inclination between 40° and 50°, in mechanically-ventilated patients.
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
- 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
- •expected mechanical ventilation duration for more than 48h after inclusion
- •signature of an informed consent by a relative
- •patient affiliated to a social security scheme (beneficiary or assignee)
排除标准
- •age<18 years old
- •mechanical ventilation with tracheotomy
- •contraindication to semirecumbent position (e.g., spinal cord injury, important sacral bedsore, counterpulsation balloon, femoral cannulation for extracorporeal circulation) or expected indication to another position within the following 48 h after inclusion (e.g., ventral decubitus for hypoxemia pulmonary pathology)
- •SAPS II score > 65 at the admission (moribund patients)
结局指标
主要结局
proportion of time spent per day in semirecumbent position as defined by a head of bed inclination between 40° and 50°
时间窗: 24hrs
head of bed inclination recording during 24h
次要结局
- head of bed inclination overall mean(24hrs)
- proportion of time spent per day with a head of bed inclination between 30° and 45°(24hrs)
- proportion of time spent per day with a head of bed inclination superior to 30°(24hrs)