Effects of Remifentanil Based Sedation on Patient-ventilator Interaction, in Patients Undergoing Noninvasive Ventilation (NIV)
试验速览
- 阶段
- 不适用
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- patient-ventilator interaction
研究概览
简要总结
In patients undergoing NIV for acute respiratory, lack of tolerance is one of the main reason of failure.
This may result in a poor synchrony between the patient and the machine, leading to gross mismatching and potentially to an increased work of breathing.
The investigators aim to investigate whether in these patients poorly responding to NIV the use of a sedation protocol using remifentanil will lead to an improve patient-ventilator interaction and better compliance to NIV.
详细描述
In patients undergoing NIV for acute respiratory, lack of tolerance is one of the main reason of failure.
This may result in a poor synchrony between the patient and the machine, leading to gross mismatching and potentially to an increased work of breathing.
The investigators aim to investigate whether in these patients poorly responding to NIV the use of a sedation protocol using remifentanil will lead to an improve patient-ventilator interaction and better compliance to NIV.
In this physiological study the investigators will study 15 patients at risk of failing NIV because of scarce tolerance and showing clinical signs of poor interaction with the ventilator.
Once the patient will be enrolled the investigators will record using the balloon-catheter technique the online measurement of respiratory mechanics, to assess the inspiratory muscle effort and the matching between the patient breathing pattern and that of the ventilator The investigators will also record the clinical success of sedation (i.e. need or not for endotracheal intubation)
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ph<7,35 and PaCO2>50 mmHg with acute respiratory failure
- •Signs of respiratory distress and poor synchrony with the ventilator as assessed on the ventilator screen and by looking patient own rate and ventilator recorded rate
排除标准
- •Patients responding well to NIV and not showing signs of poor synchrony
研究组 & 干预措施
acutely ill patients
administration of remifentanil at the infusion rate by 0.025 μg kg-1 min-1 to a maximum of 0.10 μg kg-1 min-1.
干预措施: Remifentanil (Drug)
结局指标
主要结局
patient-ventilator interaction
时间窗: one hour
patient-ventilator interaction will be assessed using the recording of respiratory mechanics to identify
Wasted efforts
时间窗: one hour
breaths unable to trigger the ventilator
matching of inspiratory timing
时间窗: one hour
the patients inspiratory time vs ventilator inspiratory time
次要结局
- NIV failure(one hour)
研究者
dr. Stefano Nava
Professor of Respiratory Medicine
IRCCS Azienda Ospedaliero-Universitaria di Bologna