NCT00647361已完成1 期
Short Term Effects of Neurally Adjusted Ventilatory Assist and Pressure Support Ventilation on Cardiac Performance
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Cardiac stroke volume index.
研究概览
简要总结
Neurally adjusted ventilatory assist (NAVA) is a new concept of mechanical ventilation. NAVA delivers assist to spontaneous breathing based on the detection of the electrical activity of the diaphragm. We study the effect of NAVA on cardiac performance in critically ill, mechanically ventilated patients.
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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female patients aged 18 - 85 years (extremes included)
- •Mechanical ventilation (tracheally intubated or tracheotomized)
- •Relevant interaction between the ventilator and the cardiac performance defined as an inspiratory deflection in central venous pressure or pulmonary diastolic pressure of ≥ 5 mmHg
- •in 10 patients with impaired cardiac performance defined as either
- •a left ventricular ejection fraction of < 40% and/or
- •treatment with dobutamine ≥2μg/kg/min, or adrenaline ≥ 3μg/kg/min and/or
- •a cardiac index of ≤ 2.2 L•min-1•m2 and/or
- •a pulmonary artery occlusion pressure (PAOP) ≥ 18 mmHg
- •in 10 patients with a history of chronic obstructive pulmonary disease (COPD) and delayed triggering-ON / cycling-OFF and/or evidence for wasted inspiratory efforts as evidenced by:
- •limitation of expiratory air flow and intrinsic PEEP as assessed by observation of the expiratory air flow curve and measurement of the airway pressure during an expiratory hold maneuver and/or
- •excessive activation of inspiratory and / or expiratory muscles as assessed by observation of the patient
- •Presence of a pulmonary artery catheter and an arterial pressure line
- •Subject itself or its next of kin has given written informed consent
排除标准
- •Patient is less than 18 years or more than 80 years of age
- •The attending physician refuses to allow enrollment
- •The patient refuses informed consent
- •Next of kin is unavailable or refuses informed consent
- •Pregnant or breast-feeding female. A pregnancy test will be performed in all female patients less than 60 years of age. The patient will not be enrolled in the study if the test result is positive.
- •Any contraindication to insertion/exchange a nasogastric tube, including (but not limited to): severe oropharyngeal malformation or bleeding; esophageal varices, tumor, infection, stenosis, or rupture
- •Presence or suspicion of diaphragm injury
- •Hemophilia or other severe bleeding disorder
- •Presence or suspicion of a central nervous system (CNS) disorder, including (but not limited to): CNS infarction, bleeding, tumor, or infection
- •History of heart and/or lung transplantation
- •Any mechanical cardiac assist device (including intraaortic balloon pump)
- •Any contraindication to reduce sedation or to stop neuromuscular blockage in order to allow spontaneous breathing
- •The patient needs to be ventilated with a mode of MV controlling for tidal volume or for airway pressure as per attending physician.
- •Severe hemodynamic instability as judged by the attending physician
- •Planned or anticipated intervention within the study period necessitating either transfer out of the ICU or requiring prolonged interaction with the patient.
- •a fraction of inspired oxygen (FiO2) of > 0.8
- •The patient currently participates in another interventional clinical trial
研究组 & 干预措施
NAVA
Experimental
干预措施: Neurally adjusted ventilatory assist (NAVA) provided by a commercially available mechanical ventilator (Servo i, Maquet Critical Care, Solna, Sweden). (Device)
结局指标
主要结局
Cardiac stroke volume index.
时间窗: end of experimental periods
次要结局
- Global delivery of oxygen(end of experimental period)
研究者
研究点 (1)
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