Crossover Study of the Cerebral Blood Flow and Cardiac Output At Different Targeted Tidal Volumes During High Frequency Oscillation with Volume Targeted Ventilation (HFO&VTV)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 27
- 试验地点
- 2
- 主要终点
- The change in the Resistive Index (RI) that will be measured on term born infants using the anterior cerebral artery Doppler on cranial ultrasound
研究概览
简要总结
Mechanical ventilation (MV) is life saving for infants requiring respiratory support in the newborn period but its use has been associated with complications. High frequency oscillation (HFO) is a type of MV that delivers small volumes of gas across the lungs at fast frequencies. HFO is a lung protective strategy but it has also been linked to brain injury due to low carbon dioxide tensions. High-frequency oscillation with volume-targeted ventilation (HFO&VTV) is a new mode of HFO in which the clinician sets a target volume of gas to be delivered to the lungs at fast rates to decrease the lung injury related to the ventilator. Further, HFO&VTV achieves better control of carbon dioxide levels and may therefore protect against brain injury. Currently, there are no written guidelines about the use of HFO&VTV. This study aim to determine the safety profile of HFO&VTV compared to HFO by comparing the velocity of blood flow to the brain in term born infants and the cardiac output in term and preterm infants during the two modes. The investigators will also determine the optimum starting value of the target tidal volume during HFOV&VTV. Infants will be studied at three different target tidal volumes for a period of 10-20 minutes each. A cranial ultrasound (for term infants only) and bedside echocardiogram will be performed at the end of each period.
详细描述
This is a single centre, randomised cross-over trial in newborn infants requiring high-frequency oscillatory ventilation (HFOV) at any postnatal age. Infants with known intracerebral pathology (stroke, hydrocephalus, intracerebral haemorrhage, severe HIE) and congenital cardiac abnormalities will be excluded from the study. In preterm infants cerebral blood flow will not be studied as there is no clear evidence for the significance of the resistive index (RI) in the cerebral arteries to predict brain injury and neurodevelopmental outcomes.
The research team will identify infants based on the inclusion criteria and approach parents to discuss the study and provide information leaflets.
The investigators aim to recruit a minimum of 25 infants (13 preterm and 12 term infants) over 18 months.
Informed written consent will be requested from the parents or legal guardians of the infants and the attending Neonatal Consultant will be requested to verbally assent to the study.
All infants will be oscillated using SLE6000 ventilators. Ventilation settings will be adjusted by the clinical team as per unit's protocol.
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
- 22 Weeks 至 1 Year（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Newborn infants of any gestation receiving high frequency oscillatory ventilation
排除标准
- •Infants with known intracerebral pathology (stroke, hydrocephalus, intracerebral hemorrhage, severe hypoxic ischemic encephalopathy).
- •Infants with congenital cardiac abnormalities.
结局指标
主要结局
The change in the Resistive Index (RI) that will be measured on term born infants using the anterior cerebral artery Doppler on cranial ultrasound
时间窗: Through study completion, an average of 18 months
次要结局
- The change in cardiac output that will be assessed with bedside ECHO in all infants(Through study completion, an average of 18 months)