To Determine if the Cardiac Output Monitoring During Cesarean Delivery Under Spinal Anesthesia Will Change Our Clinical Practice of Using Vasopressors
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Percentage of Participants With a Cardiac Output Within and Outside 20% of Baseline Values
研究概览
简要总结
The purpose of the study is to learn more about how the heart works during cesarean delivery under spinal anesthesia (medicines given in the spine that numb parts of your body to block pain) in women. The investigators would like to find out if the information about the heart can help in treating blood pressure changes that occur during the cesarean delivery. The investigators would also like to find out if this information can help reduce the chances of nausea and vomiting during the cesarean delivery.
The activity of the heart changes during spinal anesthesia and cesarean section. In the past, a sensor placed directly into the heart was the only way to see how the heart worked. Currently, there are monitors that can sense the heart's activity via sensors that are placed on the skin during cesarean delivery.
In this study, the investigators will use the ICON cardiac output (ICON) monitor. The ICON monitor is approved by the US Food and Drug Administration (FDA) to monitor (check) the activity of your heart.
This study aims to:
- Determine if additional cardiac output measurements help anesthesiologists maintain appropriate hemodynamics as defined as within 20% of baseline BP and if it changed their choice of vasopressors (primary outcome).
- Determine if additional cardiac output measurements help to decrease the incidence of nausea and vomiting during cesarean delivery (secondary outcome).
详细描述
Most women who undergo elective cesarean delivery in our hospital have spinal anesthesia for the surgery. You will receive standard spinal anesthesia techniques whether or not you take part in this study. You will be asked to sign a separate clinical consent form for the spinal anesthesia and for your cesarean delivery.
After the anesthesiologist places your spinal anesthesia, the investigator will record your blood pressure every two minutes as is the standard practice in our institution. An anesthesiologist is a doctor who specializes in giving drugs or other agents to prevent or relieve pain during surgery or other procedures. The investigator will also continuously record your heart rate and the amount of oxygen in your blood as is the standard practice. If needed, the anesthesiologist will give you medications to maintain your blood pressure.
In addition to the standard procedures described above, additional monitoring (checking) of your heart will be performed as part of this study. The investigator will use the ICON monitor to measure the amount of blood pumped by each heart beat.
The anesthesiologist will put on the sensors (sticky pads). There are four sticky pads that are similar to what is used during electrocardiograms (EKGs). Two sensors are placed on the left side of your neck and two on the left side of your trunk. The sensors have wires attached that will be plugged into a small heart monitor device that records the information.
The investigators will place the sensors on you before you receive the spinal anesthesia. The sensors will record what your heart is doing before placement of spinal anesthesia until the end of your surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
盲法说明
The investigator assigned the subject to one of the groups. Care provided followed the protocol for the group and the investigator analyzed the outcome results.
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Healthy pregnant subjects
排除标准
- •Other than healthy
- •High blood pressure. Presumed excessive bleeding, medications for blood pressure
研究组 & 干预措施
Control group
The care provider will use blood pressure and heart rate data to administer vasopressor use. In the control group, vasopressors (phenylephrine and ephedrine) will be used as considered appropriate to maintain BP within 20% of baseline. The CO data is measured and blinded to the anesthesiologists in the control group, therefore the anesthesiologist choice of ephedrine or phenylephrine is based on the individual anesthesiologist standard of care preference
Study group
The care provider will use the cardiac output monitor data (intervention) to guide vasopressors (Phenylephrine and ephedrine) in addition to blood pressure and heart rate data based on a standardized protocol in addition to the blood pressure and heart rate data available in the control group.
干预措施: Cardiac output monitor data (Device)
结局指标
主要结局
Percentage of Participants With a Cardiac Output Within and Outside 20% of Baseline Values
时间窗: intraoperatively during surgery
To determine mean cardiac output differences between the control group and the study group that used cardiac output data. In the control group, the cardiac output data was measured but not used for correcting blood pressure changes. Blood pressure changes were used for administering phenylephrine or ephedrine. In the study group, cardiac output data was used, in addition to blood pressure data, to correct both cardiac output and blood pressures to be maintained within 20% of baseline measurements. After spinal anesthesia for cesarean delivery, the cardiac output and blood pressure tends to decrease. When this occurs, the blood flow to the uterus and the baby decrease resulting in fetal heart changes. Since we do not monitor the baby during the actual cesarean delivery (technically difficult), the strategy is to maintain the blood pressure and cardiac output within the 20% of the baseline values.
次要结局
- Number of Participants With Umbilical Cord pH(Intraoperative)
- Nausea and Vomiting(intraoperatively during surgery)
研究者
Bhavani Shankar Kodali
Vice Chair, Anesthesiology
Brigham and Women's Hospital