Hemodynamic Monitoring in Obstetrics
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 148
- 试验地点
- 1
- 主要终点
- Incidence of hypotension assessed through the use of the non-invasive hemodynamic monitoring system ClearSight
研究概览
简要总结
Spinal anesthesia has long been considered the first choice technique in caesarean section, but although it is a reliable and safe procedure, it is in some cases associated with undesirable effects. Maternal hypotension after sub-arachnoid anesthesia is a reduction in systolic blood pressure below 100 mmHg or a decrease of 20% compared to baseline values. According to some authors, maternal hypotension occurs up to 80% in women undergoing caesarean section after spinal anesthesia. In order to reduce the incidence of maternal hypotension, some measures can be taken:
- a reduction of aorto-caval compression by manual displacement of the uterus on the left;
- hemodynamic monitoring;
- administration of fluids;
- optimization of the dosage of the local anesthetic;
- use of vasopressors.
The main objective of the study is to investigate, through the use of a continuous non-invasive hemodynamic monitoring system (Clearsight® - Edwards Lifesciences), the incidence of hypotension in pregnant women at risk undergoing spinal anesthesia due to elective cesarean section.
详细描述
In this prospective observational not-for profit study, 128 patients will be enrolled to measure the incidence of hypotension during spinal anesthesia for elective cesarean section. On the occasion of the preoperative visit, all patients to be subjected to elective cesarean section will be subjected to the Postural Change Test (PCT), a predictive test for maternal hypotension during spinal anesthesia that evaluate changes in heart rate of pregnant women following postural changes. Specifically, after monitoring the heart rate in the supine position, the patient is asked to change decubitus (from supine to left lateral and then back to supine). The test is positive if the patient's heart rate changes more than 10% from baseline.
Once arrived in the obstetric emergency department, parturients with positive Postural Change Test will be subjected to cannulation of a peripheral vein through a 18-20 Gauge needle cannula and the Clearsight hemodynamic monitoring system will be placed on a finger. The investigators will then proceed to the detection of the following parameters:
- Mean Blood Pressure (MAP);
- Heart Rate (HR);
- Stroke volume (SV);
- Stroke volume Index (SVI);
- Cardiac Index (CI). These data will be collected and reported in the data sheet of the study, at different time points (T0 - T9). Basal values will be collected at T0 and T1: at T0 when the patient is in the supine position and at T1 when the patient is in a lateral position. The investigators will then proceed to the administration of a crystalloid bolus (10 ml/kg) and to the execution of spinal anesthesia (T2). The spinal block needle will be inserted, compatibly to the patient's anatomical conditions, at the L3-L4 / L4-L5 spaces. 0.5% hyperbaric Bupivacaine (5 mg/ml) will be administered at a dose depending on the patient's weight and height.
Once the spinal block has been performed, the patient will be immediately placed in a supine position. The investigators will then continue monitoring the parameters listed above using Clearsight® (SV, SVI, MAP, CI) at 2-minute intervals in the phases following spinal anesthesia:
- T3: 2 minutes after spinal anesthesia,
- T4: 4 minutes after spinal anesthesia,
- T5: 6 minutes after spinal anesthesia,
- T6: 8 minutes after spinal anesthesia. The other measurements will be made at skin incision (T7), uterine incision (T8) and extraction (T9).
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
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
- •Age between 18 and 40 years
- •American Society of Anesthesiologists (ASA) Classification I-II
- •Positive Postural Change Test (PCT)
- •Signature of informed consent
排除标准
- •Age less than 18 years or above 40 years
- •American Society of Anesthesiologists (ASA) Classification III-V
- •Negative Postural Change Test (PCT)
- •Refusal by the parturients to sign the informed consent
结局指标
主要结局
Incidence of hypotension assessed through the use of the non-invasive hemodynamic monitoring system ClearSight
时间窗: Intraoperatively
次要结局
- Volume of urine excreted during surgery(Intraoperatively)
- Modifications of Stroke Volume (SV) from basal(2 minutes after extraction)
- Modifications of Stroke Volume Index (SVI) from basal(2 minutes after extraction)
- Need for inotropes and / or vasopressor during surgery(Intraoperatively)
- Number of hypotension episodes not detected by the traditional pressure cuff but detected by the Clearsight system(Intraoperatively)
- Modifications of Cardiac Index (CI) from basal(2 minutes after extraction)
- Need for fluids administration during surgery(Intraoperatively)
- Evaluation of fetal health through Apgar score(At 1 and at 5 minute after birth)
研究者
Paolo Murabito
Assistant Professor
University of Catania