Lung Protection in Acute Respiratory Distress Syndrome Using Neurally Adjusted Ventilatory Assist
试验速览
- 阶段
- 不适用
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- PaO2/FiO2 ratio
研究概览
简要总结
The aim of this study is to investigate the use neurally adjusted ventilatory assist (NAVA) as lung protective strategy in patients with acute respiratory distress syndrome (ARDS).
详细描述
Background： Acute respiratory distress syndrome (ARDS) should ventilated with a tidal volume of 4-6 ml/kg according to the ARDSnet recommendations. Due to the lack of clinical evidence of the potential role of neurally adjusted ventilatory assist (NAVA) in ARDS, investigators would like to conduct a study comparing the two modes from a lung protective point of view. Investigators believe it may have a great value in defining guidelines for improved lung protection.
Study Design： This is a prospective, pilot-randomized controlled trial n a single intensive care unit from one hospital. The study is expected to close the case a year (2018.08.01-2019.07.31).
Methods： Fifty patients with ARDS according to the Berlin Definition will enroll to this study. Patients are randomized after fulfilling inclusion and none of the exclusion criteria (25 participants will divide into study group and the other 25 participants will be control group). Patients are studied twice daily with collection of data and blood tests. All data are collected and analysis.
Effect： Tidal volumes in ARDS patients ventilated with NAVA will show tidal volumes clearly within the safe range. ARDS patients on NAVA mode will show improvements in oxygenation, gas distribution and inflammatory markers while requiring less sedatives and hemodynamic support.
Key words： Acute respiratory distress syndrome; neurally adjusted ventilatory assist; lung protective strategy.
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
- Single (Participant)
盲法说明
Participants will be randomized into study group or control group, and which is single blind processes to participants.
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
- •Diagnosis of ARDS by Berlin definition
- •P/F ratio between 100-300
- •Completed the case enrollement within 48 hours
排除标准
- •Less than 18 years old
- •Pregnancy
- •Participants with tracheostomy
- •Unable to insert the NG-tube
结局指标
主要结局
PaO2/FiO2 ratio
时间窗: 2 days
PaO2 is a data from ABG; FiO2 is the data of ventilator deliver oxygen
次要结局
- Tidal volume(2 days)
- Mechanical ventilation days(3 months)
- Length of intensive care unit stay(3 months)
- PaCO2(2 days)
- Length of hospital stay(3 months)
研究者
Ke-Yun, Chao
Group leader of Respiratory Therapists
Fu Jen Catholic University