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临床试验/NCT06473818
NCT06473818尚未招募不适用

Non-invasive vs Invasive Cardiac Output Monitoring in Patients Under Spinal Anesthesia During Cesarean Section: a Prospective Observational Study

General Hospital of Ningxia Medical University0 个研究点目标入组 50 人开始时间: 2024年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
50
主要终点
Cardiac output (CO)

研究概览

简要总结

This study aims to evaluate the consistency of hemodynamic monitoring between NICAP and NICCO technologies (T20A; Chongqing, China) and the traditional pulse wave analysis method (EV1000; USA).

详细描述

The uterine placenta lacks autonomous regulatory ability, thus making maternal cardiac output (CO) the primary source of blood supply. Therefore, monitoring hemodynamics, including maternal CO, is of significant importance and provides guidance for anesthesia decisions such as fluid management and the administration of vasopressors during cesarean section. This study aims to evaluate the consistency of hemodynamic monitoring between NICAP and NICCO technologies (T20A; Chongqing, China) and the traditional pulse wave analysis method (EV1000; USA).

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 45 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • 18-45 years
  • Primipara or multipara
  • Singleton pregnancy ≥37 weeks
  • American Society of Anesthesiologists physical status classification I to II
  • Scheduled for cesarean section under spinal anesthesia

排除标准

  • Body height < 150 cm
  • Body weight > 100 kg or body mass index (BMI) ≥ 40 kg/m2
  • Eclampsia or chronic hypertension or baseline blood pressure ≥140 mmHg
  • Hemoglobin < 7g/dl
  • Fetal distress, or known fetal developmental anomaly

结局指标

主要结局

Cardiac output (CO)

时间窗: 1-60 minutes after spinal anesthesia

Monitoring data

Cardiac index (CI)

时间窗: 1-60 minutes after spinal anesthesia

Monitoring data

Stroke volume variation (SVV)

时间窗: 1-60 minutes after spinal anesthesia

Monitoring data

Stroke volume (SV)

时间窗: 1-60 minutes after spinal anesthesia

Monitoring data

Peripheral vascular resistance

时间窗: 1-60 minutes after spinal anesthesia

Monitoring data

次要结局

  • The incidence of bradycardia(1-15 minutes after spinal anesthesia)
  • The incidence of severe post-spinal anesthesia hypotension(1-15 minutes after spinal anesthesia)
  • The incidence of nausea and vomiting.(1-15 minutes after spinal anesthesia)
  • The incidence of hypertension(1-15 minutes after spinal anesthesia)
  • The incidence of post-spinal anesthesia hypotension(1-15 minutes after spinal anesthesia.)

研究者

发起方
General Hospital of Ningxia Medical University
申办方类型
Other
责任方
Sponsor

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