Continuous Evaluation of Diaphragm Function During Assisted Mechanical Ventilation in Critically Ill Patients
试验速览
- 阶段
- 不适用
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- Diaprhagm excursion
研究概览
简要总结
Aim of mechanical ventilation is to improve gas exchange and to unload the respiratory muscles delivering a form of mechanical support to the ventilation. At the same time, it is essential that the support is individually-tailored to avoid the development of muscular atrophy, a process called "ventilatory-induced diaphragm dysfunction"
Aim of the present study is that the continuous ultrasonographic assesment of diaphragm function, as obtained by the device under investigation (DiaMon, Respinor AS, Oslo, Norway) is related to the degree of effort of inspiratory muscles, as measured by gold-standard indices such as esophageal and gastric pressure measurement.
A secondary aim is that the data assessed by the device are related to a standard ultrasonographic examination performed by expert operators.
In particular, we will enroll a population of critically ill patients undergoing mechanical ventilation in assisted mode, and we will perform a decremental pressure support trial, with the following aims:
- to evaluate the performance of a continuous and automated device for the monitoring of diaphragm contractile activity, as compared to standard mechanical indices of respiratory effort such as the pressure-time product (PTP)
- to evaluate the performance of a continuous and automated device for the monitoring of diaphragm contractile activity, as compared to the ultrasonographic assesment of muscle function performed by an expert operator.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Diagnostic
- 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
- •Acute respiratory failure which necessitated endotracheal intubation and mechanical ventilation, with ventilation in pressure-support mode.
- •Positive end-expiratory pressure (PEEP) lower than 10 cmH2O
- •Pressure support level between 4 and 10 cmH2O
- •Ratio between PaO2 and FiO2 >200 mmHg
- •Resolution of the cause of respiratory failure
排除标准
- •Diagnosis of Chronic Obstructive Pulmonary Disease (COPD)
- •Pregnancy
- •Circulatory failure
结局指标
主要结局
Diaprhagm excursion
时间窗: Study 1 day
Excursion (in mm) between expiration and inspiration
次要结局
- Esophageal pressure swing(Study 1 day)
- Pressure-time product(Study 1 day)
研究者
Davide Chiumello
Director of Intensive Care
University of Milan
