Physiologic Pilot Study: Work of Breathing Description in Neonates With Congenital Diaphragmatic Hernia in Post-surgical Period Alternatively in Conventional Ventilation (Pressure Controlled) and in NAVA (Neurally Adjusted Ventilatory Assist) Ventilation.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 8
- 试验地点
- 2
- 主要终点
- Work of breathing averaged over 100 consecutive cycles in NAVA ventilation and conventional ventilation
研究概览
简要总结
Congenital diaphragmatic hernia (CDH) is a congenital malformation associated with significant mortality and respiratory morbidity, particularly related to prolonged mechanical ventilation. NAVA (Neurally Adjusted Ventilatory Assist) is a recent technique that uses the recognition of the electrical activity of the patient's diaphragm (Edi) and delivers a synchronized proportional assisted ventilation. This technique has already been used in the newborn, especially premature and has shown many benefits. Only one study in the literature shows its feasibility in newborns with CDH. This technique seems interesting in the context of CDH because it would limit baro-trauma and improve synchronization. Before demonstrating the clinical benefits, it seems important to describe the effects on the respiratory physiology, in particular on work of breathing which can be estimated by the esophageal and trans-diaphragmatic pressure-time product obtained by an esophageal transducer. Our study is an innovative physiologic pilot study with the objective to describe work of breathing in neonates with CDH in post-surgical period in NAVA ventilation and in conventional ventilation using an esophageal transducer. It will provide the clinician with a physiological justification for the use of NAVA to rapidly improve the respiratory muscular dynamics of these patients. This study is a prerequisite for the realization of studies demonstrating the clinical benefit of NAVA ventilation on reduction of duration of ventilation and more generally on morbidity and mortality in the population of neonate with CDH.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 1 Year 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Neonate admitted to neonatal intensive care beyond 34 weeks of amenorrhea
- •With a diagnosis of congenital diaphragmatic hernia having undergone a repair surgery.
- •Necessary invasive ventilatory support by conventional ventilation
- •Informed and signed consent of parents (and / or holders of parental authority)
排除标准
- •Refusal of parents (and / or holders of parental authority) to participate in the study
- •Contra-indication to the use of an oro or naso-gastric tube (oesophageal surgery)
- •Child at risk of poor tolerance to the placement of the oesophageal pressure transducer (history of discomfort when placing a tube, weight <1500g)
- •Central or neuromuscular neurological pathology which may affect respiratory control
结局指标
主要结局
Work of breathing averaged over 100 consecutive cycles in NAVA ventilation and conventional ventilation
时间窗: in post-surgical period during 6 hours
Work of breathing is estimated by the esophageal and trans-diaphragmatic pressure-time product obtained by an esophageal transducer
次要结局
- Ventilation parameters: Ti / Ttot ratio in NAVA(through study completion, an average of 1 year)
- Ventilation parameters: Ti / Ttot ratio in conventional ventilation(through study completion, an average of 1 year)
- Ventilation parameters: mean pressure in NAVA(through study completion, an average of 1 year)
- Ventilation parameters: FiO2 in NAVA(through study completion, an average of 1 year)
- Patient-ventilator synchronization in NAVA(through study completion, an average of 1 year)
- Patient-ventilator synchronization in conventional ventilation(through study completion, an average of 1 year)
- Ventilation parameters: mean pressure in conventional ventilation(through study completion, an average of 1 year)
- Clinical parameters of neonates: heart rate in NAVA(through study completion, an average of 1 year)
- Ventilation parameters: peak inspiratory pressure in conventional ventilation(through study completion, an average of 1 year)
- Ventilation parameters: tidal volume in NAVA(through study completion, an average of 1 year)
- Physiological parameters indirectly evaluating work of breathing: diaphragmatic swing in conventional ventilation(through study completion, an average of 1 year)
- Gas exchange: measurement of transcutaneous SaO2 in NAVA(through study completion, an average of 1 year)
- Neonate comfort scores: COMFORT-BEHAVIOR score in NAVA(through study completion, an average of 1 year)
- Dynamic hyperinflation (intrinsic PEEP) in NAVA(through study completion, an average of 1 year)
- Dynamic hyperinflation (intrinsic PEEP) in conventional ventilation.(through study completion, an average of 1 year)
- Ventilation parameters: peak inspiratory pressure in NAVA(through study completion, an average of 1 year)
- Ventilation parameters: tidal volume in conventional ventilation(through study completion, an average of 1 year)
- Ventilation parameters: FiO2 in conventional ventilation(through study completion, an average of 1 year)
- Physiological parameters indirectly evaluating work of breathing: esophageal swing in NAVA(through study completion, an average of 1 year)
- Physiological parameters indirectly evaluating work of breathing: diaphragmatic swing in NAVA(through study completion, an average of 1 year)
- Clinical parameters of neonates: respiratory rate in NAVA(through study completion, an average of 1 year)
- Clinical parameters of neonates: blood pressure in NAVA(through study completion, an average of 1 year)
- Physiological parameters indirectly evaluating work of breathing: esophageal swing in conventional ventilation(through study completion, an average of 1 year)
- Clinical parameters of neonates: blood pressure in conventional ventilation(through study completion, an average of 1 year)
- Gas exchange: measurement of transcutaneous pCO2 in NAVA(through study completion, an average of 1 year)
- Gas exchange: measurement of transcutaneous SaO2 in conventional ventilation(through study completion, an average of 1 year)
- Neonate comfort scores: COMFORT-BEHAVIOR score in conventional ventilation(through study completion, an average of 1 year)
- Clinical parameters of neonates: respiratory rate in conventional ventilation(through study completion, an average of 1 year)
- Clinical parameters of neonates: heart rate in conventional ventilation(through study completion, an average of 1 year)
- Gas exchange: measurement of transcutaneous pCO2 in conventional ventilation(through study completion, an average of 1 year)