Pulse Wave Analysis and Augmentation Index Changes Associated With Neuraxial Anesthesia in the Parturient
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- Occurrence of hypotension following spinal anesthesia. Defined as systolic BP > 20% from baseline.
研究概览
简要总结
A fall in blood pressure (hypotension) occurs in one third of spinal anesthetics administered to pregnant patients undergoing cesarean delivery. However, predicting which patients will experience hypotension following spinal anesthesia has proven difficult. Pulse wave analysis is a repeatable and reproducible method for investigation of cardiovascular function. A device called a SphygmacorTM can be used to measure pulse. The pulse measurement is called the Augmentation Index (AIx). AIx has been useful in detecting risks associated with blood pressure changes after complex surgery in patients with heart and blood vessel disease. In this study the investigators wish to see if it is possible to predict if a subject will experience hypotension based on her AIx measurement preoperatively.
详细描述
At BC Women's Hospital (BCWH), anesthesiologists give spinal anesthesia for most elective cesarean deliveries. When the spinal medication is given, blood vessels expand in reaction to the spinal medication causing blood pressure to fall. If a patient experiences this common reaction, the anesthesiologist would administer some medications to restore blood pressure to normal. They do this to protect the blood supply to the placenta and to the baby.
It is not known why this happens in some people and not in others. The way blood circulates through the body can provide information about changes occurring in the body. Pulse measurements are a simple way of providing physicians with important clinical information about patient health.
A device called a SphygmacorTM can be used to measure a pulse. The pulse measurement is called the Augmentation Index (AIx). AIx has been useful in detecting risks associated with blood pressure changes after complex surgery in patients with heart and blood vessel disease. In our study we wish to see if AIx can predict a normal patient's risk of hypotension after spinal anesthesia. If a trend between AIx and the onset of hypotension after spinal anesthesia can be found, anesthesiologists can more effectively prevent and treat hypotension by being able to predict whether it will occur.
Consenting subjects will have their blood pressure and AIx measurement taken prior to surgery.
Surgery will commence as per usual practice at BCWH. If hypotension occurs after the spinal anesthesia, anesthesiologist will treat as per usual practice.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 19 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •All women undergoing elective or urgent cesarean delivery under spinal anesthesia
- •Singleton Pregnancy
- •Greater than 37 weeks gestation
- •Healthy subjects with ASA 1 & 2 classification of health
- •Potential subjects need to be able to read and understand English unless independent (non-partner) translator available
排除标准
- •ASA 3 or above
- •Emergency cesarean delivery for fetal heart rate abnormalities
- •Cesarean delivery under general, epidural, or combined spinal epidural anesthesia
- •Maternal age <19 years
- •Maternal infection
- •Mothers with vascular disease - including hypertension/pre-eclampsia
- •Mothers with Diabetes Mellitus
- •Polyhdramnios
- •Multiple Pregnancy
- •Height < 150cm or > 180cm
- •BMI > 40
结局指标
主要结局
Occurrence of hypotension following spinal anesthesia. Defined as systolic BP > 20% from baseline.
时间窗: 1 week
次要结局
- Augmentation Index as measured by the SphygmacorTM preoperatively; Bradycardia requiring pharmacological treatment; Ephedrine requirement; Phenylephrine requirement; Block Height; Nausea/vomiting(1 week)