Clinical Evaluation of an Automated Knowledge-based Computer Driven System (SmartCare/PS-NIV) Designed to Automatically Adapt Pressure Support Level and Expiratory Cycling During Non Invasive Ventilation, a Feasability Study.
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 11
- 试验地点
- 2
- 主要终点
- Feasibilty of using the Smartcare-NIV system to deliver non-invasive ventilation in case of acute respiratory failure.
研究概览
简要总结
Knowledge-based systems were initially developped to automatically adapt pressure support settings during invasive ventilation, and proved to be at least as efficient as experienced clinicians.
Non-invasive ventilation has become the standard of care for patients suffering from acute hypercapnic respiratory failure (ARF)and has reduced the need for endotracheal intubation in these patients, thus reducing their hospital mortality.
NIV success or failure is closely related to the tolerance of NIV treatment, which is tightly correlated to patient-ventilator synchrony. As severe asynchronies frequently occurs during NIV (namely in more than 40% of patients) and as the occurence of asynchronies is related to the use of high pressure support levels, to the presence of leaks and/or to non optimal expiratory trigger settings, very frequent ventilator settings adaptations should allow reducing patient-ventilator asynchronies but require the presence of an experienced clinician at the bedside during NIV treatment.
A computer-driven ventilator settings adaptation has the adavantage of permitting very frequent ventilator settings adaptation whithout requiring the presence of an experienced clinician at the bedside and could possibly improve patient-ventilator interaction.
The aim of the present study is to test the faisability of using the Smartcare NIV computer-driven system to automatically adapt ventilator settings during non invasive ventilation delivered because of acute respiratory failure.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Acute respiratory failure requiring non invasive ventilation
- •ICU patient equipped with an arterial line.
排除标准
- •Contra-indications to NIV:
- •impaired consciousness
- •absence of patient cooperation
- •severe hemodynamic instability
- •facial lesions
- •indication for immediate intubation
- •Acute neurological problem
- •Poor short term prognosis
结局指标
主要结局
Feasibilty of using the Smartcare-NIV system to deliver non-invasive ventilation in case of acute respiratory failure.
时间窗: 45 minute NIV-treatment
The main aim of the study is to explore the feasibility of using the Smartcare-NIV system to deliver non-invasive ventilation (NIV) in case of acute respiratory failure. Practically, we will describe how the NIV tratment will go on when using the Smartcare system and report how the system automatically adapt the ventilator settings.
次要结局
- Leaks(45 minutes)
- O2 saturation(45 minutes)
- Blood gas analysis(45 minutes)
- Tidal volumes(45 minutes)
- Alarms generated by the ventilator(45 minutes)
- Blood pressure(45 minutes)
- Respiratory rate(45 minutes)
- Manual ventilator settings modifications required(45 minutes)
- Heart rate(45 minutes)
- Minute ventilation(45 minutes)
- Patient-ventilator asynchronies(45 minutes)
- Patient comfort(45 minutes)
- Percentage of time spent in a predifined comfort zone.(45 minutes)
研究者
Prof. Philippe Jolliet
Principal investigator
University of Lausanne Hospitals