Noninvasive High Frequency Oscillatory Ventilation as a Post-extubation Respiratory Support in Preterm Neonates: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Re-intubation rate
研究概览
简要总结
A randomized controlled trial comparing Noninvasive high frequency oscillatory ventilation (NHFOV) and Noninvasive positive pressure ventilation (NIPPV) as post-extubation respiratory support in preterm neonates with respiratory distress syndrome(RDS)
详细描述
The use of noninvasive respiratory support (NRS) has increased in recent decades in Neonatal Intensive Care Unit (NICU) as a means to reduce ventilator-induced lung injury. Various modes of NRS are available and in common use. However despite extensive research, the optimal modality of noninvasive modes remain unknown.
Noninvasive high-frequency oscillatory ventilation (NHFOV) is a relatively new mode. It consists of the application of a continuous distending positive pressure with superimposed oscillations. It is a method of augmenting Continuous positive airway pressure (CPAP) support potentially combining the advantages of both high-frequency oscillatory ventilation and CPAP.
The new NHFOV technique offers improved carbon dioxide (CO2) removal and increased functional residual capacity. The superimposed oscillations of NHFOV are thought to help avoid gas trapping and upregulate mean airway pressure.
This technique is also characterized by lower tidal volume resulting in fewer barotraumas /volutraumas and not needing synchronization. NHFOV was considered a strengthened version of CPAP.
The hypothesis is that NHFOV might be superior to NIPPV as a post-extubation respiratory support strategy to avoid reintubation and subsequent complications and/or sequelae in preterm infants.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 1 Minute 至 1 Month（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Preterm neonates with gestational age ≤ 35 weeks.
- •Neonates that were on invasive mechanical ventilation for at least 48 hours eligible for extubation
排除标准
- •Patients with major upper or lower airway anomalies.
- •Patients with significant congenital anomalies including cardiac, abdominal or respiratory.
研究组 & 干预措施
noninvasive high frequency oscillatory ventilation (NHFOV)
After documenting parental consent, the ventilated infants eligible for extubation were randomly assigned to NHFOV as post extubation noninvasive respiratory support
干预措施: noninvasive high frequency oscillatory ventilation (Device)
noninvasive positive pressure ventilation (NIPPV)
After documenting parental consent, the ventilated infants eligible for extubation were randomly assigned to NIPPV as post extubation noninvasive respiratory support
干预措施: noninvasive positive pressure ventilation (Device)
结局指标
主要结局
Re-intubation rate
时间窗: 72 hours
Percentage of Patients who failed weaning on the assigned noninvasive mode and needed reintubation to the total number of patients assigned to that mode.
次要结局
- Duration of admission(8 weeks or till patient discharge which comes first)
- Mortality rate(8 weeks or till patient death which comes first)
- Days on supplemental oxygen(8 weeks or till patient discharge which comes first)
- Days on the assigned non-invasive respiratory support(8 weeks or till patient discharge which comes first)
- Lung ultrasound score(Before extubation and after 2 hours on assigned mode)
- Co2 change(Before extubation and after 2 hours on assigned mode)
- Oxygen requirement(Before extubation and after 2 hours on assigned mode)
- Incidence of feeding intolerance(8 weeks or till patient weaning from assigned mode which comes first)
- Days to reach full intake(8 weeks or till patient discharge which comes first)
- Intracranial hemorrhage(8 weeks or till patient weaning from assigned mode which comes first)
- Pneumothorax(8 weeks or till patient weaning from assigned mode which comes first)
- Incidence of occurrence of Nasal trauma(8 weeks or till patient weaning from assigned mode which comes first)
- incidence of bronchopulmonary dysplasia(8 weeks or till patient discharge which comes first)
- Severity of respiratory distress(Before extubation and and after 2 hours on assigned mode)
- Need for Postnatal Steroids(8 weeks or till patient discharge which comes first)
- Chest x ray change(Before extubation and and after 2 hours on assigned mode)
研究者
Sondos Ahmed Salaheldin Ahmed
Assistant lecturer
Ain Shams University