Role of Type of Respiratory Circuit and Type of Ventilator on Asynchronies During Non-invasive Ventilation (NIV) in Children With Acute Respiratory Failure: an Interventional, Nonpharmacological Crossover Study
试验速览
- 阶段
- 不适用
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Asynchrony Index
研究概览
简要总结
The term ''Non-invasive ventilation'' (NIV) refers to various methods of respiratory assistance, in the absence of an indwelling endotracheal tube. In recent years, the use of NIV has increased for the treatment of both acute and chronic pediatric respiratory failure. Patient tolerance to the technique is a critical factor determining its success in avoiding endotracheal intubation. One of the key factors determining tolerance to NIV is optimal synchrony between the patient's spontaneous breathing activity and the ventilator's set parameters, known as ''patient-ventilator interaction''.
Indeed, synchronization of the ventilator breath with the patient's inspiratory effort, optimizes comfort, minimizes work of breathing and reduces the need for sedation. During NIV, several factors can significantly interfere with the function of the ventilator, leading to an increased risk of asynchrony. Indeed, the presence of unintentional leaks at the patient-mask interface, the sensitivity of inspiratory and expiratory triggers, the ability to compensate for intentional and unintentional leaks and the presence/absence of expiratory valves are all factors that likely play a role in determining patient-ventilator synchronization.
The investigators therefore designed the present crossover trial in order to compare the degree of respiratory asynchronies during NIV using different ventilators (Turbine-driven ventilator vs. compressed air-driven ICU ventilators) and different setups (single circuit vs. double circuit) in children with acute respiratory failure.
详细描述
After having obtained the signed informed consent from the parents of the patient, a 6 Fr pediatric esophageal balloon-catheter will be placed through a nostril in the distal third of the esophagus.
This minimally invasive procedure, will allow to monitor and record esophageal pressure swings, which are strongly correlated to pleural pressure variations and therefore allow to detect accurately patients' inspiratory efforts. Furthermore, surface electrodes will be placed in order to record the electrical activity of the diaphragm non-invasively.
In every patient, three breathing trials (30 minutes each) will be performed in randomized order:
- NIV performed with a double limb circuit and expiratory valve incorporated in the ventilator, delivered with a pediatric/neonatal ICU ventilator (Babylog VN500, Draeger).
- NIV performed with a single limb circuit and intentional leak (vented mask) delivered with a turbine-driven ventilator (Astral 150 [ResMed] ).
- NIV performed with a double limb circuit and expiratory valve incorporated in the ventilator, delivered with the same turbine-driven ventilator of point 2 (Astral 150 [ResMed]).
The NIV setting decided clinically will not be modified for the study and will be held constant throughout the different study phases. Similarly, if sedative drugs are being delivered to the patient, the attending physician will decide their dose and it will be kept constant throughout the study phases. The Comfort scale will be assessed for each study phase, in order to evaluate and describe the comfort/distress of the patients during the different ventilatory strategies. Esophageal pressure tracings, inspiratory/expiratory air flows, airway pressure measured at the patient-ventilator interface and electrical activity of the diaphragm (measured with surface electrodes) will be continuously recorded with a dedicated software throughout the study in order to compute, offline, the asynchrony index (see below).
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
- Single (Outcomes Assessor)
盲法说明
Analysis of respiratory tracings will be blinded to the type of respiratory support.
入排标准
- 年龄范围
- 1 Month 至 4 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with acute hypoxic (SpO2/FIO2 ratio < 315) or hypercapnic (PvCO2 > 52 mmHg and venous pH <7.28) respiratory failure in which non-invasive respiratory support is clinically indicated
- •Age: > 28 days and < 4 years
- •Patients whose parents provided signed informed consent
排除标准
- •Age > 4 years or < 28 days
- •Patients whose parents did not provide signed informed consent
- •Clinical contraindications to non-invasive ventilation
- •Clinical contraindication to the placement of an esophageal balloon
结局指标
主要结局
Asynchrony Index
时间窗: 90 minutes
Difference in Asynchrony index \[expressed as percentage\] between different modalities of Non-invasive ventilation.
次要结局
- Ineffective efforts(90 minutes)
- Auto-triggering(90 minutes)