Comparison of Primary Extubation Failure Between Non-invasive Positive Pressure Ventilation (NIPPV) and Non Invasive Neural Access Ventilatory Assist (NI-NAVA)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Extubation success
研究概览
简要总结
Extubation failure is a significant problem in preterm neonates and prolonged intubation is a well-documented risk factor for development of chronic lung disease. Out of the respiratory modalities available to extubate a preterm neonate; high flow nasal canula, nasal continuous positive airway pressure (nCPAP) and noninvasive positive pressure ventilation (NIPPV) are the most commonly used.
A recent Cochrane meta-analysis concluded that NIPPV has lower extubation failure as compared to nCPAP (30% vs. 40%)
NAVA (neurally adjusted ventilatory assist), a relatively new mode of mechanical ventilation in which the diaphragmatic electrical activity initiates a ventilator breath and adjustment of a preset gain (NAVA level) determines the peak inspiratory pressure. It has been reported to improve patient - ventilator synchrony and minimize mean airway pressure and ability to wean an infant from a ventilator. However till date there has been no head to head comparison of extubation failure in infants managed on NAVA with conventional ventilator strategies.
In this study the investigators aim to compare primary extubation failure rates in infants/participants managed by NIPPV vs. NI-NAVA (non invasive NAVA). Eligible infants/participants will be randomized to be extubated to predefined NIPPV or NI-NAVA ventilator settings and will be assessed for primary extubation failure (defined as reintubation within 5 days after an elective extubation).
详细描述
Mechanical ventilation is needed for most preterm infants to maintain adequate oxygenation and ventilation. However the coexistence of lung immaturity, weak respiratory drive, excessively compliant chest wall, and surfactant deficiency often contribute to dependency on mechanical ventilation during the first days or weeks after birth.
Prolonged mechanical ventilation is associated with high mortality and morbidities including ventilator-associated pneumonia, pneumothorax, and bronchopulmonary dysplasia (BPD). Each additional week of mechanical ventilation is reported to be associated with an increase in the risk of neurodevelopmental impairment. Reduction in the need and duration of invasive mechanical ventilation may potentially improve outcome of preterm infants.
Extubation failure has been independently associated with increased mortality, longer hospitalization, and more days on oxygen and ventilatory support. It is critical, therefore, to attempt extubation early and at a time when successful extubation is likely.
A recent Cochrane review compared the use of nasal intermittent positive pressure ventilation (NIPPV) with nasal continuous positive airway pressure (nCPAP) in preterm infants after extubation and found that NIPPV may be more effective than nCPAP at decreasing extubation failure.
The feasibility of NAVA use has been described in neonatal and pediatric patients. Several studies cite a decrease in peak inspiratory pressures, improved synchrony in triggering, and more appropriate termination of positive pressure support. Some studies have reported lower work of breathing, PaO2/FiO2 ratios (partial pressure of oxygen/ fractional inspired oxygen)and MAP. In addition, NAVA has been used for patients who "fight the ventilator," and the synchrony improves the ability to wean.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
盲法说明
provider and PI is masked for randomization but then no masking once treatment (mode of ventilation) is applied
入排标准
- 年龄范围
- 24 Weeks 至 32 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Infants born between 24 weeks and ≤ 32 weeks completed gestational age or birth weight less than or equal to 1500 grams
- •Postnatal age ≤ 14 days
- •Mechanically ventilated for at least 12 hrs.
- •Intubated within first 24 hrs. after birth
- •Outborn infants intubated and transferred to UF within 24 hrs. after birth.
排除标准
- •Outborn > 24hrs of age.
- •Failed elective extubation prior to study enrollment
- •Major congenital anomalies or known/suspected chromosomal anomalies
- •Use of paralytics in previous 24 hrs.
- •Participation in another randomized interventional trial
- •Known or suspected phrenic nerve palsy or lesion
- •Known or suspected diaphragmatic lesion
- •Any contraindication to have a nasogastric or orogastric tube placement
结局指标
主要结局
Extubation success
时间窗: 5 days
assess how many infants stayed extubated at 5 days after extubation
次要结局
- Necrotizing enterocolitis (NEC(until discharge / 36 weeks post menstrual age)
- Abdominal distension > 2cm from baseline and with signs necessitating cessation of feeds during the first 48 hrs. after extubation(until discharge / 36 weeks post menstrual age)
- Gastrointestinal perforation(until discharge / 36 weeks post menstrual age)
- Mortality(until discharge / 36 weeks post menstrual age)
- Extubation failure at 3 days(until discharge / 36 weeks post menstrual age)
- Severe intraventricular hemorrhage(until discharge / 36 weeks post menstrual age)
- Ventilator Days(until discharge / 36 weeks post menstrual age)
- Extubation failure at 7 days(until discharge / 36 weeks post menstrual age)
- Retinopathy of prematurity (ROP)(until discharge / 36 weeks post menstrual age)
- Bronchopulmonary dysplasia (BPD)(until discharge / 36 weeks post menstrual age)
- NICU length of stay(until discharge / 36 weeks post menstrual age)
- Patent ductus arteriosus (PDA)(until discharge / 36 weeks post menstrual age)
- Late onset sepsis(until discharge / 36 weeks post menstrual age)
- Pulmonary air leak(until discharge / 36 weeks post menstrual age)
- Ventilator associated Pneumonia (VAP)(until discharge / 36 weeks post menstrual age)