Controlled Trial Evaluating the Interest of Noninvasive Ventilation in NAVA Mode in Respiratory Decompensations Children With Infantile Spinal Muscular Atrophy Type II
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1
- 试验地点
- 1
- 主要终点
- Asynchrony percentage
研究概览
简要总结
The new NAVA® ventilatory mode with the SERVO-i ventilator (Maquet®) uses the electrical activity of the diaphragm (EADi) as a marker for triggering the respiratory cycle. The EADi is captured by the electrodes of a specific catheter (the Edi® catheter) placed in the esophagus as a regular gastric feeding tube, and relayed to the SERVO-i who displays it and delivers respiratory assistance according to measured Edi signal which allows synchronous assistance, proportional to the respiratory efforts of the patient.
To date, no measure of the effectiveness of NAVA NAV has been performed in children with neuromuscular pathology whereas this technique could reduce the use of invasive ventilation, very iatrogenic in these fragile subjects.
详细描述
This is a prospective, interventional, sequential, open-label research involving ASI II children with acute respiratory decompensation requiring ventilatory support by NIV. Airway pressure, transcutaneous CO2 monitoring and hemodynamic parameters will be recorded continuously during the study, after inclusion of the patient.
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
- 1 Year 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age above 1 year and under 18 years
- •Patient hospitalized in the pediatric intensive care unit.
- •Acute respiratory decompensation requiring non-invasive ventilation for more than 6 hours.
- •Patient with traditional NIV support less than 12 hours and still showing an indication for a non-invasive ventilatory support.
- •Affiliation to the French health insurance organism
- •Consent signed by the two holders of parental authority for the child participation in the research.
排除标准
- •Contraindications to the use of NAVA or the setting up of a nasogastric tube.
- •Hemodynamic instability requiring the use of vasopressor amines, adrenaline, norepinephrine or dobutamine.
- •Severe respiratory instability requiring imminent intubation or FiO2> 60%, or PaCO2> 80 mmHg.
- •Limitation of life support treatments discussed or decided.
研究组 & 干预措施
Single arm
Single arm trial, every patient enroll in this study will follow the same protocol with classic and NAVA mode non-invasive ventilation.
干预措施: NAVA (Device)
结局指标
主要结局
Asynchrony percentage
时间窗: At baseline
Asynchrony percentage of non-synchronous breath cycles over all cycles of the measurement period, unaided breaths, self-initiated cycles.
次要结局
- Feasibility(At baseline)
- Efficacy and tolerance(At 30 minutes and 60 minutes)
- Rate of recourse to intubation(At baseline)