Effect of Volume Guarantee-High Frequency Oscillatory Ventilation on Cerebral Blood Flow in Preterm Neonates
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Doppler cerebral blood flow velocity measurements
研究概览
简要总结
A randomized controlled clinical trial evaluates cerebral blood flow changes associated with HFOV-VG in comparison to HFOV alone in preterm neonates with respiratory insufficiency during the period of invasive respiratory support
详细描述
Neonatal respiratory distress (NRD) is one of the most common problems in the first few days of neonatal life. NRD has been reported to be prevalent in 5 - 29% of the NICU hospitalized neonates.
High-frequency oscillatory ventilation (HFOV) has been used for more than three decades, it is a rescue maneuver for failed conventional mechanical ventilation. It delivers small tidal volumes to improve gas exchange. As it uses a low tidal volume, under the anatomical dead space at supra-physiological respiratory frequencies HFOV can reduce the risk of lung injury related to the ventilator and consequently reduce the risk of bronchopulmonary dysplasia HFOV is indicated for patients with neonatal air leak syndrome, persistent pulmonary hypertension, and meconium aspiration Several factors are known to influence cerebral perfusion during HFOV. Hypercapnia increases cerebral blood flow (CBF) while a reduction in PaCO2 leads to cerebral vasoconstriction and decreases CBF, Hypoxia is also known to increase CBF via cerebral vasodilation HFOV with volume guarantee (HFOV-VG) is a promising new ventilator mode for the treatment of respiratory failure in newborns. HFOV-VG is expected to result in less lung injury since it reduces fluctuations of high frequency tidal volume (VThf), reduces the number of out-of-target pCO2 values and provides fewer hypoxia attacks compared with HFOV alone
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 1 Day 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 with various causes of respiratory failure: respiratory distress syndrome (RDS), air leak syndromes, pneumonia, or pulmonary hemorrhage, failing with conventional ventilation (i.e. when conventional ventilation failed to maintain either oxygenation or ventilation) and are switched to HFOV as a rescue therapy.
排除标准
- •Preterm neonates with major upper or lower airway anomalies.
- •Preterm neonates with significant congenital anomalies including cardiac, abdominal or respiratory
研究组 & 干预措施
High Frequency Oscillatory Ventilation with Volume Guarantee (HFOV-VG )
After documenting parental consent, preterm neonates with respiratory insufficiency randomly ventilated on (HFOV-VG ) will be assessed by doppler cerebral blood flow velocity measurements
干预措施: High Frequency Oscillatory Ventilation with Volume Guarantee (SLE6000;SLE) (Device)
High Frequency Oscillatory Ventilation (HFOV)
After documenting parental consent, preterm neonates with respiratory insufficiency randomly ventilated on (HFOV) will be assessed by doppler cerebral blood flow velocity measurements
干预措施: High Frequency Oscillatory Ventilation (SLE6000;SLE) (Device)
结局指标
主要结局
Doppler cerebral blood flow velocity measurements
时间窗: 72 hours
Investigate the effect of combining the VG mode with HFOV (HFOV-VG), versus the effect of HFOV alone, on Doppler cerebral blood flow velocity measurements
次要结局
- Mortality rate(8 weeks or till patient death which comes first)
- Incidence of feeding intolerance(8 weeks or till patient discharged)
- efficiency of HFOV-VG in comparison with HFOV alone(8 weeks or till patient discharged)
- Duration of admission(8 weeks or till patient discharged)
- Days to reach full intake(8 weeks or till patient discharge which comes first)
- Chest x ray change(Before intubation and and after 2 hours on assigned mode)
研究者
Mohamed Abdullah Moussa Akid
Assistant lecturer
Ain Shams University