Assessment of the Value of Passive Leg Raising (PLR) in Predicting the Onset of Maternal Arterial Hypotension and Norepinephrine Requirements After Spinal Anesthesia for Scheduled Cesarean Section.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 64
- 试验地点
- 2
- 主要终点
- Positivity of passive leg raise test
研究概览
简要总结
Spinal anesthesia for cesarean section is associated with a high incidence of low blood pressure. However, the pathophysiology of this arterial hypotension is not unequivocal and could involve, in addition to drug vasoplegia, a mechanical cause linked to lower caval compression or even true or relative hypovolemia. Passive leg raise test has been proposed in an attempt to identify parturients who are more likely to develop low blood pressure after spinal anesthesia. Nevertheless, the data available on this volume expansion test to predict hemodynamic variations after performing spinal anesthesia are still limited and few objective criteria have been described to predict this arterial hypotension.
The objective of the research is to study the hypothesis according to which the presence of hypovolaemia (true or relative) objectified by a positive passive leg raise test would cause hypotension more frequent and more marked in intensity.
详细描述
Spinal anesthesia for cesarean section is associated with a high incidence of low blood pressure. However, the pathophysiology of this arterial hypotension is not unequivocal and could involve, in addition to drug vasoplegia, a mechanical cause linked to lower caval compression or even true or relative hypovolemia.
Passive leg raise test has been proposed in an attempt to identify parturients who are more likely to develop low blood pressure after spinal anesthesia. Nevertheless, the data available on this volume expansion test to predict hemodynamic variations after performing spinal anesthesia are still limited and few objective criteria have been described to predict this arterial hypotension.
The objective of the research is to study the hypothesis according to which the presence of hypovolaemia (true or relative) objectified by a positive passive leg raise test would cause hypotension more frequent and more marked in intensity.
Patients will have a clinical hemodynamic and echocardiographic evaluation, before performing the spinal anesthesia, before and after the passive leg raise test.
Then, the patients will benefit from a clinical hemodynamic evaluation during the preparation of the parturient in the operating room and finally after the completion of the spinal anesthesia and until the clamping of the umbilical cord.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Adult women admitted to Necker Enfants Malades hospital for scheduled cesarean section under spinal anesthesia
- •Written informed consent
排除标准
- •No health insurance
- •Urgent cesarean
- •Failure of spinal anesthesia
- •Free and informed consent impossible to obtain (especially due to a language barrier)
- •Severe cardiovascular or neurovascular comorbidities
- •Contraindication to the PLR (intracranial hypertension, fractures of the pelvis and / or lower limbs, ...)
- •Background of preeclampsia or eclampsia
- •Severe fetal pathology
结局指标
主要结局
Positivity of passive leg raise test
时间窗: Day 0
A positive passive leg raise test is defined as an increase in the Subaortic Flow Velocity Time Integral of 10% or more. The increase in cardiac output is measured by a cardiac ultrasound.
Maternal arterial hypotension
时间窗: Day 0
Maternal arterial hypotension following spinal anesthesia. Maternal hypotension is defined as a drop in systolic blood pressure (SBP)\> 20% of baseline.
Positive passive leg raise test performance
时间窗: Day 0
Performance of a positive passive leg raise test in predicting the onset of maternal arterial hypotension after spinal anesthesia. Significant performance will be defined by sensitivity and specificity \> 90%.
次要结局
- Assessment of fetal well-being(Day 0)
- Relative or absolute hypovolemia(Day 0)
- Right ventricle systolic or diastolic dysfunction(Day 0)
- Onset of nausea and vomiting(Day 0)
- Occurrence of disturbances of consciousness(Day 0)
- Quality of ultrasound images(Day 0)
- Total dose of norepinephrine(Day 0)
- Onset of severe arterial hypotension(Day 0)
- Pericardial effusion(Day 0)
- Maternal comfort during the passive leg raising(Day 0)
- Heart rate(Day 0)
- Occurrence of sedation and agitation(Day 0)
- Left ventricle systolic and diastolic dysfunction(Day 0)