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临床试验/NCT06195774
NCT06195774尚未招募不适用

Impact on Respiratory Function Associated to Epidural Analgesia in Parturient Women as Assessed by Electrical Impedance Tomography: a Monocentric Prospective Study

Erasme University Hospital1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2024年1月最近更新:
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
100
试验地点
1
主要终点
Regional lung ventilation (ROI 1-4)

研究概览

简要总结

The goal of this observational study is to learn more about the effect of obstetric epidural anesthesia on regional lung ventilation in healthy parturient women. The main question it aims to answer is whether the initiation or epidural analgesia improves or not regional lung ventilation in healthy women at term during labor.

Participants will be subject to measurements of pulmonary impedance by electric impedance tomography before and after the start of epidural analgesia. No change will be applied to clinical care as a result of this measurement.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

性别
Female
接受健康志愿者

入选标准

  • At-term pregnancy (at least 36 weeks)
  • ASA class I-II

排除标准

  • American Society of Anesthesiologists (ASA) Class III or more
  • BMI>35 before pregnancy
  • Contraindication to routinely administrated drugs (levobupivacaine, lidocaine, sufentanil)
  • Contraindication to epidural analgesia
  • Pregnancy-related complications (including pre-eclampsia)
  • Respiratory system diseases
  • Severe psychiatric disorders
  • Twin pregnancy
  • Skin lesions in correspondence to the position of the Electric impedance tomography belt
  • Pacemaker or Implantable Cardioverter Defibrillator (ICD)
  • Language barrier

结局指标

主要结局

Regional lung ventilation (ROI 1-4)

时间窗: "before" measurements will be taken just before applying lumbar epidural analgesia, and "after" measurements will be taken 5 minutes and ten minutes after starting lumbar epidural analgesia. Measurements take 10 minutes of continuous registration

Assess regional ventilation as measured by electric impedance in each of the 4 Regions Of Interest (from anterior to posterior) in which the lung is divided, before and after epidural analgesia

次要结局

未报告次要终点

研究者

发起方
Erasme University Hospital
申办方类型
Other
责任方
Sponsor

研究点 (1)

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