Patient-ventilator Interaction During NIV With Helmet: a Comparison Between PSV and the New NIV NPS Software
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Improvement of synchrony in nPSV v.s PSV
研究概览
简要总结
The goal of this clinical trial is to evaluate if neural pressure support ventilation is able to improve patient-ventilator synchrony, in ICU patients undergoing non-invasive ventilation (NIV). The main question it aims to answer is:
• Is neural pressure support ventilation better than the pressure support ventilation with respect to patient-ventilator synchrony during helmet NIV?
Researchers will compare neural pressure support ventilation versus pressure support ventilation (Gold standard assisted mode in Europe) to see if the new mode improve patient-ventilator synchrony.
详细描述
Non-Invasive Ventilation (NIV) has found many different uses in clinical settings, shortening intubation times and preventing orotracheal intubation. NIV success is highly affected by patient comfort and patient-ventilator synchrony. The helmet is one of the most comfortable interfaces, even if synchrony is low due to dead space. The use of Neurally Adjusted Ventilatory Assist (NAVA), in which the Electrical Activity of the Diaphragm (EAdi) drives the ventilator, has shown improvement in comfort and synchrony but still some limitation with helmet, due to the long pressurization time. Pressure-Support Ventilation (PSV) is still the most used and diffused assisted mode in Europe due to its simplicity and effectiveness in helmet-NIV. The aim of this study is to test a new ventilation software called Neural Pressure Support Ventilation (nPSV), which merges the rapid pressurization of PSV along with the EAdi trigger, onto a population of 24 critical care patients ventilated with a helmet NIV.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
盲法说明
All the patients will be ventilated in both modes.
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
- •Adult patients (>18aa)
- •Non Invasive Ventilation with helmet
- •NG tubing for clinical use in position
- •Invasive arterial monitoring for clinical use in position
排除标准
- •Unable to express consent
- •Expected NIV < 24hrs
- •Gastric-esophageal surgery in the preceding 12 months
- •Upper-GI bleeding in the last 30 days
- •History of esophageal varices
- •Recent trauma or facial surgery
- •Haemodynamic instability even a after liquid infusion (need of at least dopamine >5 γ/kg/min or norepinephrine >0.1 γ/kg min to obtain systolic pressure >90 mmHg)
- •Core temperature >30 C°
- •Coagulation disorders (INR > 1.5 and/or aPTT >44 sec)
结局指标
主要结局
Improvement of synchrony in nPSV v.s PSV
时间窗: last 2 minutes over 30 minutes registration
Synchrony time \[Timesych\]: time frame during which both the ventilator and the neural patient inspiratory time are in the inspiratory phase (s)
次要结局
- Respiratory rate(last 2 minutes over 30 minutes registration)
- Inspiratory time(last 2 minutes over 30 minutes registration)
- Peak of Electrical Activity of the diaphragm(last 2 minutes over 30 minutes registration)
- Minute Volume(last 2 minutes over 30 minutes registration)
- Tidal Volume(last 2 minutes over 30 minutes registration)
- Neural Inspiratory Time(last 2 minutes over 30 minutes registration)
- Inspiratory Neural-Ventilator Coupling(last 2 minutes over 30 minutes registration)
- Asynchrony index(last 2 minutes over 30 minutes registration)
研究者
Davide Colombo
Doctor
ASL Novara