Impact of NAVA (Neurally Adjusted Ventilatory Assist) on Ventilatory Demand During Pediatric Non-Invasive Ventilation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- The ventilatory demand of the patient in each ventilatory conditions, evaluated by the mean electrical diaphragmatic activity
研究概览
简要总结
Mechanical ventilation permits to support the work of breathing in case of respiratory failure, but therapy also has many side effects. Non-invasive ventilation (NIV), which delivers the ventilatory assist via a face mask or nasal canula, permits to decrease these complications. However, NIV is not always successful and half of children in respiratory failure finally require invasive ventilation. A major cause of NIV failure is the ventilator inability to detect patient efforts. The new ventilatory mode NAVA (neurally adjusted ventilatory assist) improves the detection of patient efforts during mechanical ventilation. The hypothesis of this study is that NAVA improves synchrony during pediatric NIV and therefore permits to unload the patient ventilatory efforts.
详细描述
Nasogastric tube installation to monitor electrical activation of the diaphragm (EAdi):
A specific nasogastric tube equipped with an array of microelectrodes (Edi catheter, Maquet, Solna, Sweden) will be installed after inclusion. This tube has an external aspect and size (6F, 8F, or 12F depending on the patient size) similar to usual nasogastric tubes. The gastric tube installation is extremely frequent in pediatric ICU, and systematic in patients with ventilatory support, to empty the gastric gas and permit the feeding. The new tube will stay in place after the study and could be used as a classic tube. The catheter position in esophagus will be adjusted using a special window of the Servo i ventilator screen, which permits to confirm the correct positioning close to the diaphragm [Barwing 2009]. It has recently been confirmed that Edi catheter placement is not difficult and that the correct placement of the nasogastric tube is actually facilitated by the possibility of activity monitoring [Green 2011].
RIP jacket installation:
A special jacket adapted to the patient size will be installed to monitor the lung volume changes by impedance plethysmography (RIP). This sleeveless jacket is constituted of a large band of distensible cloth in which 2 metallic coils are coated to record the impedance changes created by the ventilation. The RIP coils will be connected to the RIP monitoring module, and no volume calibration will be done to avoid the manipulation of patient airway. RIP monitoring is completely non-invasive and no complications are expected [Emeriaud 2010][Emeriaud 2008].
Baseline measurements:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 3 Days 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children >3 days and <18 years old
- •Hospitalized in the pediatric intensive care unit, and requiring non invasive ventilation (including any ventilatory modes, with one (CPAP) or two level of pressure assist) for more than 6 hours according to the prescription of the attending physician
排除标准
- •Contraindications to NAVA use or to the placement of a new nasogastric tube (e.g. bilateral phrenic paralysis, trauma or recent surgery in cervical, nasopharyngeal or esophageal regions)
- •Hemodynamic instability requiring dopamine ≥ 5µg/kg/min, epinephrine, norepinephrine, or dobutamine.
- •Severe respiratory instability requiring imminent intubation according to the attending physician, or FiO2 > 60%, or PaCO2>80 mmHg on blood gas in the last hour.
- •Absence of parental or tutor consent.
- •Patient for whom a limitation of life support treatments is discussed or decided
结局指标
主要结局
The ventilatory demand of the patient in each ventilatory conditions, evaluated by the mean electrical diaphragmatic activity
时间窗: up to 28 days
The analysis of respiratory recordings will be conducted on 15 minute period during which the patient is not agitated, at the end of the 3 ventilation periods: baseline period with conventional parameters, NAVA period, and 2nd period with conventional parameters. The mean EAdi will be calculated as the area under the curve of EAdi versus time
次要结局
- Percentage of time spent in asynchrony(Up to 28 days)
研究者
Dr Guillaume Emeriaud
MD, PhD
St. Justine's Hospital