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临床试验/NCT05921955
NCT05921955已完成不适用

Effect of Maternal Oxygen Supplementation by High-flow Nasal Oxygen Compared With Room Air on Fetal Acidemia

Beijing Tongren Hospital1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2023年7月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
120
试验地点
1
主要终点
umbilical artery lactate, mmol/L

研究概览

简要总结

The study propose that the using the high-flow nasl oxygen to provide oxygen for maternal can improve the fetal acidemia and the neonatal outcomes during cesarean section with combined spinal-epidural anesthesia.

详细描述

Maternal oxygen supplementation is widely used intrauterine resuscitation technique in clinical, which can improve fetal oxygenation and prevent fetal acidemia. The incidence of hypotension is high in cesarean section with combined spinal-epidural anesthesia. Hypotension contributes to insufficient perfusion of uterus and placenta, resulting in decreased fetal oxygen supply and neonatal acidemia. High flow nasal oxygen have a better improvement oxygenation of patients by providing high flow oxygen airflow with heating and humidification through nasal cannula.

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
Double (Participant, Outcomes Assessor)

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

  • An elective cesarean section in Beijing Tongren Hospital
  • ≥37 weeks' gestation
  • American society of Aneshesiologists(ASA) I-III
  • Aged 18 to 45 years old
  • The fasting time is 6-8h, and the water restriction time is ≥2h
  • Anesthesia: combined spinal-epidural anesthesia
  • Agree to the study and sign the informed consent

排除标准

  • Fetal or placental abnormalities are known
  • Maternal has complications
  • Maternal BMI ≥40 kg/m2
  • History of difficult intubation or known difficult airway
  • Contraindications for HFNO such as nasal lesions or structural changes
  • Gastric reflux disease

结局指标

主要结局

umbilical artery lactate, mmol/L

时间窗: the fetal delivery

mmol/L

次要结局

  • umbilical artery partial pressure of carbon dioxide(PCO2)(the fetal delivery)
  • umbilical artery base excess(BE), mmol/L(the fetal delivery)
  • umbilical artery pH value(the fetal delivery)
  • the incidence of pH<7.20 and pH<7.10(the fetal delivery)
  • umbilical artery oxygen partial pressure(PO2)(the fetal delivery)

研究者

发起方
Beijing Tongren Hospital
申办方类型
Other
责任方
Sponsor

研究点 (1)

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