Ventilator Weaning Outcome Between Non-invasive Neural Adjusted Ventilator Assist and Nasal Continuous Positive Airway Pressure (or Intermittent Mandatory Ventilation) Modes in Premature Neonates
试验速览
- 阶段
- 不适用
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Duration of mechanical ventilation
研究概览
简要总结
Premature neonates are prone to respiratory distress and need ventilator support because of the rapid breathing and large variations in respiratory patterns. The setting and adjustment of the ventilator for premature neonate is not easy, often resulting in poor patient-ventilator interaction, increased work of breathing, patient discomfort and delayed weaning . Recently, a new ventilation mode (NAVA; Neurally Adjusted Ventilatory Assist) mode, allows the respirator to provide a proportional ventilation mode based on the patients' diaphragm electrical activity, which was validated in many domestic and international clinical researches. The NAVA mode improves patient-ventilator interaction, reduces work of breathing and contributes to early weaning and extubation . When participating in this study, the neonate with receive a special oral tube placement, which is used to replace the original gastric tube to monitor the electrical activity of the diaphragm.
详细描述
Premature neonates are prone to respiratory distress and need ventilator support because of the rapid breathing and large variations in respiratory patterns. The setting and adjustment of the ventilator for premature neonate is not easy, often resulting in poor patient-ventilator interaction, increased work of breathing, patient discomfort and delayed weaning . Recently, a new ventilation mode (NAVA; Neurally Adjusted Ventilatory Assist) mode, allows the respirator to provide a proportional ventilation mode based on the patients' diaphragm electrical activity, which was validated in many domestic and international clinical researches. The NAVA mode improves patient-ventilator interaction, reduces work of breathing and contributes to early weaning and extubation . When participating in this study, the neonate with receive a special oral tube placement, which is used to replace the original gastric tube to monitor the electrical activity of the diaphragm. The aims of the study are: 1. To select the appropriate ventilation mode and parameters (for example, switch to NIV-NAVA mode); 2. To monitor intermittent apnea, bradycardia and the frequency of cyanosis, 3. To pay attention to the changes in maximum peak pressure, adjust appropriate pressure support, and avoid lung injury. The predicted outcomes of NAVA mode for premature neonate may include : 1. Measurement of the lower PIP value to maintain proper and synchronized ventilation; 2. Monitoring of the diaphragm activity (Edi) signal to evaluate the work of breathing and estimate the weaning time.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 30 Weeks 至 37 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Premature >30week
- •Respiratory distress
排除标准
- •Premature < 30weeks
- •ENT contraindication: fistula
- •Contraindication with orogastric tube or nasogastric
结局指标
主要结局
Duration of mechanical ventilation
时间窗: Until the date of discharge from ICU, up to 4 weeks
Defined as the time from the start of mechanical ventilation, defined as either the time of in the ICU and until successful weaning mechanical ventilator, with successful weaning defined as ≥5 days of unassisted spontaneous breathing after .
次要结局
- Length of ICU stay(Until the date of discharge from ICU, up to 4 weeks)
- Length of hospital stay(Until the date of discharge from ICU, up to 4 weeks)
- Daily patient physiological blood gas status(Until the date of discharge from ICU, up to 4 weeks)
- Difference in the number of patient ventilator asynchrony(Entire period of ventilatory support, an average of 7 days)
- Ventilation parameters: peak inspiratory pressure in NIV-NAVA(Entire period of ventilatory support, an average of 7 days)
- Ventilation parameters : tidal volume in NIV-NAVA(through study completion, an average of 7 days)
- Ventilation parameters : PEEP in NIV-NAVA(through study completion, an average of 7 days)
- Ventilation parameters : FiO2 in NIV-NAVA(through study completion, an average of 7 days)
- Ventilation parameters : Edi peak in NIV-NAVA(through study completion, an average of 7 days)
- Ventilation parameters : Edi min in NIV-NAVA(through study completion, an average of 7 days)
- Ventilation parameters : peak inspiratory pressure in NCPA (or NIMV)(through study completion, an average of 7 days)
- Ventilation parameters : tidal volume in NCPA(or NIMV)(through study completion, an average of 7 days)
- Ventilation parameters : PEEP in NCPA (or NIMV)(through study completion, an average of 7 days)
- Ventilation parameters : FiO2 in NCPA or NIMV(through study completion, an average of 7 days)
- Ventilation parameters : pressure control level in NIMV(through study completion, an average of 7 days)
- Ventilation parameters : RR in NIMV(through study completion, an average of 7 days)
- Clinical parameters of Premature: heart rate in NIV-NAVA(through study completion, an average of 7days)
- Clinical parameters of Premature: respiratory rate in NIV-NAVA(through study completion, an average of 7days)
- Clinical parameters of Premature: SpO2 in NIV-NAVA(through study completion, an average of 7days)
- Clinical parameters of Premature: blood pressure in NIV-NAVA(through study completion, an average of 7days)
- Clinical parameters of Premature: heart rate in NCPA(or NIMV)(through study completion, an average of 7days)
- Clinical parameters of Premature: respiratory rate in NCPA (or NIMV)(through study completion, an average of 7days)
- Clinical parameters of Premature: blood pressure in NCPA (or NIMV)(through study completion, an average of 7days)
- Clinical parameters of Premature: SpO2 in NCPAP(or NIMV)(through study completion, an average of 7days)