Feasibility Study Over the Neurally Adjusted Ventilatory Assist (NAVA) Mode in Noninvasive Ventilation After Cardiac Surgery in Infants.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Evaluation of the percentage of asynchronies during the nava mode
研究概览
简要总结
Neonates who underwent cardiac surgery with cardiopulmonary bypass almost always require non-invasive respiratory support (NIV) in relay to conventional ventilation. Current nasal interfaces do not generally allow synchronised bilevel ventilation. NIV-NAVA mode allows, through an oesophageal catheter, to record the electrical activity of the diaphragm and thereby synchronize breaths from the ventilator on the inspiratory efforts of the child. Moreover, the pressure support delivered by the ventilator may be proportional to the diaphragmatic effort developed by the child. This mode, associated with the interface Miniflow®, could increase the comfort of the child by allowing a more efficient synchronization and reducing its respiratory work. To our knowledge, this ventilation mode with this interface has not been evaluated in the postoperative period of cardiac surgery in the newborns. The purpose of this study is to evaluate the feasibility of this ventilatory mode and evaluate its influence on ventilatory parameters of this category of infants.
详细描述
Study Design:
Single centre prospective crossover study
Study Objectives:
Main objectives:
- Assessment of the feasibility of non invasive ventilation in NIV-NAVA mode via Miniflow® interface in infants of less than 3.5 kg after cardiac surgery with cardiopulmonary bypass.
- Evaluation of the following parameters:
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
入排标准
- 年龄范围
- — 至 12 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Weight ≤ 5 kg
- •Postoperative period of cardiac surgery with cardiopulmonary bypass (max 10 days after surgery)
- •Conventional ventilation
- •Agreement with the extubation criteria
- •Arterial line
排除标准
- •High frequency oscillation ventilation
- •Extubation criteria not fulfilled
- •Proven or suspected sepsis
- •Absence of arterial line
- •Oesophageal pathology (Excepted gastro-oesophageal reflux)
结局指标
主要结局
Evaluation of the percentage of asynchronies during the nava mode
时间窗: from minute zero to minute 90
One of the aims of the NAVA mode is to provide better synchronization between the child's breathing needs and the breathing cycles given by the ventilator. By comparing the EDI curve (electric activity of the diaphragm of the child) and the flow and pressure curves of the ventilator, it is possible to determine the percentage of asynchronies during the nava mode
次要结局
- Comparison of PaCO2 between nasal Continuous Positive Airway Pressure (nCPAP) mode and NIV-NAVA mode(from minute zero to minute 90)
- Comparison of blood pH between nasal Continuous Positive Airway Pressure (nCPAP) mode and NIV-NAVA mode(from minute zero to minute 90)
- Comparison of Inspiratory Pressure between nasal Continuous Positive Airway Pressure (nCPAP) mode and NIV-NAVA mode(from minute zero to minute 90)
- Comparison of breathing rhythm between nasal Continuous Positive Airway Pressure (nCPAP) mode and NIV-NAVA mode(from minute zero to minute 90)
- Comparison of PEEP (positive end expiratory pressure) between nasal Continuous Positive Airway Pressure (nCPAP) mode and NIV-NAVA mode(from minute zero to minute 90)
- Comparison of FiO2 between nasal Continuous Positive Airway Pressure (nCPAP) mode and NIV-NAVA mode(from minute zero to minute 90)
- Comparison of PaO2 between nasal Continuous Positive Airway Pressure (nCPAP) mode and NIV-NAVA mode(from minute zero to minute 90)