Assessment of Cerebral Vasoreactivity Using Near-infrared Spectroscopy (NIRS) in Infants
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Assessment of the changes in TOI and THI as measured by NIRS under normocapnia and permissive hypercapnia
研究概览
简要总结
The purpose of this study is to show that a permissive hypercapnia during mechanical ventilation in children under general anaesthesia will improve cerebral perfusion.
详细描述
Mechanical ventilation interferes with cerebral perfusion via the changes in intrathoracic pressure and/or as a consequence of hypocapnia. This latter occurs frequently following traditional ventilation strategies with relatively high tidal volume and respiratory rate. New trends in anesthesia intend to promote protective lung ventilation by keeping a normocapnic or even mildly hypercapnic state. However, cerebral vascular vasotonicity is carbon dioxide (CO2)-dependent with hypocapnia potentially leading to vasoconstriction and subsequent decrease in cerebral blood flow. Changes in cerebral vasoreactivity can be assessed by the near infrared spectroscopy (NIRS) device. This monitoring evaluates the changes in various parameters (deoxygenated hemoglobin, oxygenated hemoglobin, the tissue oxygenation index (TOI) and the tissue hemoglobin index (THI)) that act as surrogate for cerebral vasoconstriction.
We, therefore designed this prospective observational comparative effectiveness study in order to characterize the potential beneficial effect of permissive hypercapnia on cerebral perfusion in infants.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 1 Day 至 1 Year（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •term neonates during their infancy
- •for elective surgery requiring general anesthesia and endotracheal intubation
排除标准
- •all infants with cardiac anomalies, chronic pulmonary disease (bronchopulmonary dysplasia, cystic fibrosis, asthma), pulmonary hypertension or cranial hypertension will be excluded
- •all infants where no access to the forehead is possible as a consequence of the operating field
研究组 & 干预措施
Normocapnia
The Child will be ventilated in order to achieve an end-tidal carbon dioxide (ETCO2) of 5.5 kiloPascal (kPa). Measurements will be performed after steady state condition. Then the ventilation will be reduced to allow ETCO2 to reach 6.5 kPa before repeating the measurements. Finally, the child will be again ventilated to obtain a normocapnia condition.
干预措施: Normocapnia (Other)
Mild Hypercapnia
The Child will be ventilated in order to achieve a ETCO2 of 6.5 kPa. Measurements will be performed after steady state condition. Then the ventilation will be increased to allow ETCO2 to reach 5.5 kPa before repeating the measurements. Finally, the child will be again ventilated to obtain a mild hypercapnic condition
干预措施: Mild Hypercapnia (Other)
结局指标
主要结局
Assessment of the changes in TOI and THI as measured by NIRS under normocapnia and permissive hypercapnia
时间窗: At steady state (2-3 minutes) after achieving each level of ETCO2 and every 2 minutes up to 6 minutes for each level
次要结局
- Body temperature(At steady state (2-3 minutes) after achieving each level of ETCO2 and every 2 minutes up to 6 minutes for each level)
- Blood Pressure(At steady state (2-3 minutes) after achieving each level of ETCO2 and every 2 minutes up to 6 minutes for each level)
- Blood gas analysis(5 or 20 minutes after reaching the steady state with ETCO2)
- Heart rate(At steady state (2-3 minutes) after achieving each level of ETCO2 and every 2 minutes up to 6 minutes for each level)
研究者
Walid HABRE
Associated Professor
University Hospital, Geneva