Analysis of Changes in the Pulse Oximeter Waveform and Blood Pressure During Spinal Anaesthesia for Caesarean Section: an Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- 1. To download electronic data which describe the pulse oximeter pulse wave to accurately assess movement of the diastolic wave relative to the systolic wave during spinal anaesthesia for caesarean section.
研究概览
简要总结
BACKGROUND:
Hypotension occurs commonly during spinal anaesthesia for caesarean section and may result in detrimental effects to the mother and foetus. A previous pilot study where images of the pulse oximeter waveform study were taken, found that the dicrotic wave moved away from the systolic wave during the onset of hypotension.
AIMS:
The investigators wish to download electronic data which describe the pulse oximeter pulse wave to more accurately assess movement of the diastolic wave relative to the systolic wave during spinal anaesthesia for caesarean section.
METHODOLOGY:
20 women undergoing caesarean section under spinal anaesthesia will be recruited by informed consent for this observational study. Data downloaded from the pulse oximeter will be analysed to identify movement of the dicrotic wave relative to the systolic wave and this will be related to changes in blood pressure.
EXPECTED OUTCOMES:
The investigators will establish best way to analyse changes in the pulse oximeter waveform and the relationship between changes in pulse oximeter waveform morphology and the onset of hypotension during spinal anaesthesia for caesarean section.
IMPLICATIONS:
Analysis of movement of the dicrotic wave could be used to anticipate and thus avoid severe hypotension during spinal anaesthesia for caesarean section.
详细描述
BACKGROUND:
When a baby is delivered by a surgical procedure (a caesarean section) the women will usually have a spinal anaesthetic. With a spinal anaesthetic local anaesthetic is injected into the spinal fluid to make the woman numb from her chest to her feet allowing her to be comfortable but awake during the birth. One of the common side effects of a spinal anaesthetic is that the woman's blood pressure may fall making her feel unwell and (rarely) causing stress to the unborn baby.
During a caesarean section the blood pressure is usually measured every few minutes using a cuff around the upper arm. However, the blood pressure may fall too quickly to be detected in a timely fashion by this intermittent means. One of the other monitors used in all cases is called a pulse oximeter. When this is attached to the patient's finger it detects the pulse rate and how much oxygen there is in the blood. The pulse oximeter also produces an image of the pulse wave in the finger. There is one pulse wave for every time the heart beats and it has two components. The main part of the wave (the systolic wave) is caused by the heart beat and the second part of the wave (the dicrotic wave) is a result of some of the energy from the heart beat bouncing back from blood vessels.
In a previous study we used a digital camera to take images of the pulse oximeter monitor screen so that we could record changes in the shape of the pulse wave. We found that as patients' blood pressure fell the dicrotic wave moved further away from the systolic wave. We now intend to down load the electronic data that make up the pulse oximeter waveform, so that we can analyse the changes that occur more accurately.
We believe that falling blood pressure may be detected earlier using analysis of movement of the dicrotic wave than by our standard monitoring. This is because currently blood pressure is measured intermittently whereas the pulse oximeter waveform is displayed continuously. Drugs could then be given promptly to stop the blood pressure from falling so low that the woman feels unwell or the unborn baby is affected.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients with an uncomplicated pregnancy presenting for elective caesarean section under spinal anaesthesia where surgery and anaesthesia are anticipated to be uncomplicated.
排除标准
- •Conditions which may impair the ability of the technology to read accurately such as:
- •Reduced peripheral perfusion e.g. Raynaud's phenomenon
- •Circulating pigments e.g. bilirubin
- •Nail varnish that cannot be removed Diseases of pregnancy: e.g. pregnancy induced hypertension Significant co-existing maternal disease - e.g. congenital heart disease Inability to speak fluent English
结局指标
主要结局
1. To download electronic data which describe the pulse oximeter pulse wave to accurately assess movement of the diastolic wave relative to the systolic wave during spinal anaesthesia for caesarean section.
时间窗: Data will be downloaded for approximately 20 minutes
Data will be collected during planned caesarean section under spinal anaesthesia
次要结局
- Vascular behaviour(twenty minutes)
- Time course of cardiovascular changes(twenty minutes)
- Preliminary cardiovascular data(twenty minutes)