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临床试验/NCT06729827
NCT06729827已完成不适用

Non-invasive PREDIctive Hemodynamic Continuous moniToring vs Standard Intermittent Blood Pressure and Post-spinal hypotensION During Elective Cesarean Section: a Randomized Clinical Trial

Fondazione Policlinico Universitario Agostino Gemelli IRCCS1 个研究点 分布在 1 个国家目标入组 102 人开始时间: 2025年3月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
102
试验地点
1
主要终点
AUC-MAP<65 mmHg 20 min

研究概览

简要总结

Single shot spinal anesthesia (SA) is the most commonly used technique for Caesarean section (CS) .

SA is associated with maternal hypotension (Post Spinal Hypotension - PSH) often accompanied by nausea, vomiting, bradycardia and fetal acidosis.

Preventive administration of vasopressors is widely used to counterbalance hypotension.

Routine prophylactic infusion of phenylephrine and norepinephrine raises concerns for unnecessary treatment, reactive hypertension, baroreceptor-mediated bradycardia, and effects on fetal acidosis.

Non-invasive continuous measurement of arterial pressure using a finger cuff is well established. Hypotension Prediction Index - HPI is an algorithm that could predict the onset of hypotension in working on invasive and non-invasive arterial waveform signal.

The aim of this prospective randomized study is to compare the amount of PSH during elective caesarean section among two groups of patients receiving standard intermittent hemodynamic monitoring versus continuous ClearSight-HPI monitoring. The primary hypothesis is that hemodynamic management HPI-guided reduces the incidence, entity and duration of post-spinal hypotension, defined as mean arterial pressure (MAP) lower than 65 mmHg lasting more than one minute.

The secondary aim was to study the impact of maternal PSH during CS on foetal outcome evaluated by comparing neonatal Apgar scores at 1 and 5 minutes after birth, and umbilical cord arterial and venous pH in the two groups.

详细描述

Caesarean section (CS) is one of the most commonly performed operations worldwide, with 1 in 5 women (21.1%) currently giving birth through this route.

The introduction of neuraxial techniques determined an improved safety, better postoperative analgesia, reduction in hemorrhage, higher Apgar scores in the neonate and a more participative birth experience.

Single shot spinal anesthesia (SA) is the most commonly used technique because it provides rapid onset, effective and reliable anesthesia.

SA induces a sympathetic block that almost inevitably produces maternal hypotension (Post Spinal Hypotension - PSH) often accompanied by nausea, vomiting and bradycardia. Sustained PSH may lead to decreased utero-placental blood flow and fetal acidosis. For this reason, the optimal management of hypotension in this setting has become one of the most active areas of research in obstetric anesthesia. In particular, preventive administration of vasopressors directly counter arteriolar vasodilation and decreased systemic vascular resistance and, by maintaining vascular tone in venous and splanchnic vessels, increases venous return and cardiac filling.

Although proactive vasopressor administration is now considered the strategy of choice for PSH, the ideal drug, dose, and mode of delivery have been debated. Studies comparing prophylactic phenylephrine infusions and rescue boluses doses have shown conflicting results. Routine prophylactic vasopressor infusion raises concerns for unnecessary or even inappropriate treatment, particularly when hypotension is unlikely to develop (50%). In other words, half of the patients, those not experiencing spinal-induced hypotension, may be exposed to unnecessary vasopressor infusion potentially developing adverse effects such as hypertension, tachycardia, Takotsubo cardiomyopathy, ventricular arrhythmias. Prophylactic phenylephrine infusions have gained favor, as recommended by the latest published international consensus statement. On the other hand, continuous vasopressors infusions may be detrimental to hemodynamic homeostasis, potentially resulting in reactive hypertension or precipitating a baroreceptor-mediated bradycardia, which in turn may result in reduced maternal CO: indeed, cardiac output decreases significantly with increasing phenylephrine rate. Norepinephrine prophylaxis is gaining popularity in clinical practice because of less bradycardia and higher maternal CO compared with phenylephrine prophylaxis. Nevertheless, concerns about an effect of norepinephrine on fetal acidosis were raised by several authors: lower umbilical pH using continuous infusion of vasopressors probably result from placental transfer and stimulation of foetal metabolism.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Full term pregnancy
  • Elective cesarean section under spinal anesthesia
  • Age > 18 years

排除标准

  • refusal to participate to the study
  • preeclampsia
  • cardiovascular diseases
  • neuromuscular disease;
  • emergent or urgent cesarean delivery;
  • coagulopathies;
  • contraindications to spinal anesthesia.

研究组 & 干预措施

Predictive monitoring - HPI

Experimental

In the HPI-group the patients will be treated with a bolus of norepinephrine 5 mcg each time that HPI is 85 or higher.

干预措施: Hypotension prediction Index - HPI (Device)

Control group

No Intervention

In the control group a rescue bolus of norepinephrine 5 mcg will be administered by the anesthesia care provider whenever MAP decreases below 65 mmHg.

结局指标

主要结局

AUC-MAP<65 mmHg 20 min

时间窗: In the first 20 min after Spinal Anesthesia

Area under the curve (AUC) for Mean Arterial Pressure \< 65 mmHg.

次要结局

  • Fetal wellbeing - 2(After 5 min from the birth of the fetus)
  • TWA-MAP < 65 mmHg(At the end of the surgery.)
  • Fetal wellbeing - 1(At the birth of the fetus)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

FRASSANITO LUCIANO

Dr Luciano Frassanito

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

研究点 (1)

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