Neurally Adjusted Ventilatory Assist for Neonates With Congenital Diaphragmatic Hernias
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 18
- 试验地点
- 2
- 主要终点
- Oxygenation Index (OI)
研究概览
简要总结
Congenital Diaphragmatic Hernias (CDH) are typically repaired surgically in the first few days of a neonate's life. Following surgical repair, infants usually require ventilatory support to ensure adequate oxygenation. Traditionally assist control ventilation (ACV) has been used to support neonates with CDH. Due to delivering a fixed pressure of oxygen, ACV has been associated with barotrauma and long-term lung damage. A more recent approach to ventilation is non-invasive neurally adjusted ventilatory assist (NIV-NAVA). NIV-NAVA uses electrical signals of the diaphragm to deliver a proportional pressure of oxygen. Our dual-centre randomised cross-over trial aims to investigate the efficacy of NIV-NAVA compared to ACV for supporting neonates with CDH.
详细描述
Background:
Congenital Diaphragmatic Hernias (CDH) are typically repaired surgically in the first few days of a neonate's life. Following surgical repair, infants usually require ventilatory support to ensure adequate oxygenation. Traditionally assist control ventilation (ACV) has been used to support neonates with CDH. Due to delivering a fixed pressure of oxygen, ACV has been associated with barotrauma and long-term lung damage. A more recent approach to ventilation is non-invasive neurally adjusted ventilatory assist (NIV-NAVA). NIV-NAVA uses electrical signals of the diaphragm to deliver a proportional pressure of oxygen. Evidence suggests that NAVA may reduce physiological parameters associated with lung pressure and hence reduce the risk of iatrogenic lung injury.
Aims:
Our aim is to compare the oxygenation index (OI) of neonates with CDH, ventilated with ACV and NIV-NAVA. The OI is calculated as the fractured of inspired oxygen x mean airway pressure x partial pressure of oxygen/100. The oxygenation index is used as a marker of hypoxic respiratory failure in infants with CDH and forms the basis of the criteria to administer nitric oxide.
Methods:
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
- None
盲法说明
Due to practical limitations, the trial will be open label.
入排标准
- 年龄范围
- 1 Minute 至 28 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Infants born with congenital diaphragmatic hernia more than 34-weeks gestation
排除标准
- •Receiving Nitric Oxide
- •Requiring an FIO2 more than 80% to maintain SpO2: 85-95%.
- •Severe chromosomal abnormality
- •Severe cardiac anomalies requiring corrective surgery
- •Renal anomalies
- •Skeletal deformities suspected to impede thoracic or lung development
- •Severe central nervous system anomalies suspected to impede diaphragmatic signalling
- •Use of neuromuscular blocking agents
- •Contraindication to nasogastric tube insertion
结局指标
主要结局
Oxygenation Index (OI)
时间窗: Infants will receive each mode of ventilation for four hours. OI will be recorded every 5-minutes for the final 30-minutes of each ventilation period. The OI will be averaged over the 30-minute time frame. This average OI will then be compared.
Oxygenation Index is calculated as MAP x FIO2 x PaO2/100. MAP is the mean airway pressure. FIO2 represents the concentration of inspired oxygen and PAO2 is the partial pressure of oxygen. The OI is a reliable indicator of lung function, previous research has shown its use in the prognostication of neonates with CDH.
次要结局
- Respiratory Severity Score (RSS)(RSS will be recorded every 5-minutes for the final 30-minutes that the infant is on each ventilation mode. This will be compared to their baseline 30-minutes pre-randomisation and between ventilation modes.)
研究者
Anne Greenough
Professor of Neonatology and Clinical Respiratory Physiology
King's College Hospital NHS Trust