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临床试验/NCT02523755
NCT02523755已完成4 期

Evaluation of Regional Distribution of Ventilation in Spontaneous Breathing Patients During Labor With or Without Epidural Analgesia Using EIT (Electrical Impedance Tomography)

Universitair Ziekenhuis Brussel1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2015年9月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
40
试验地点
1
主要终点
Better lung function after labor with epidural analgesia

研究概览

简要总结

With an efficient epidural analgesia the physiological effects of pain are disabled during labor. Pain may cause an increase of minute volume, oxygen consumption and a decrease of paCO2 (Arterial CO2 pressure). The study will evaluate the lung function before and after labor with and without epidural analgesia. With more efficient breathing, the occurence of atelectasis should be reduced; this effect will be investigated in these settings for the first time with the electrical impedance tomography, which is a completely non-invasive measure.

详细描述

The bedside efficacy of the electrical impedance tomography (EIT) in intensive care settings during mechanical ventilation is known. However, no studies demonstrate its utility during epidural analgesia for labor.

The purpose of this study is to evaluate lung function and atelectasis in pregnant women with or without epidural analgesia, during labor and after delivery.

Only adult consenting patients ASA I & ASA II (American Society of Anaesthesiologists) are included in the study. According to institutional protocols lumbal epidural catheter is inserted and tested at the start of the labor, while patients' parameters are monitored.

Refusal to epidural analgesia, technical difficulties to insert the epidural catheter or any medical contraindication will result in inclusion of these patients in the control group.

Measurement with EIT is not invasive and harmful neither for the mother nor for the child.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
None

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

  • 未提供

排除标准

  • Caesarian
  • < 18 years
  • Expulsions

研究组 & 干预措施

Epidural analgesia Ropivacaine

Active Comparator

Placement of an epidural catheter to achieve pain relief

干预措施: Epidural analgesia Ropivacaine (Drug)

Epidural analgesia Ropivacaine

Active Comparator

Placement of an epidural catheter to achieve pain relief

干预措施: Absence of epidural analgesia (Drug)

Absence of epidural analgesia

Sham Comparator

No placement of an epidural catheter either because of patient refusal or contraindication

干预措施: Epidural analgesia Ropivacaine (Drug)

Absence of epidural analgesia

Sham Comparator

No placement of an epidural catheter either because of patient refusal or contraindication

干预措施: Absence of epidural analgesia (Drug)

结局指标

主要结局

Better lung function after labor with epidural analgesia

时间窗: 24h

Using EIT we will map the degree of atelectasis

次要结局

未报告次要终点

研究者

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

Veerle Van Mossevelde

Data Nurse

Universitair Ziekenhuis Brussel

研究点 (1)

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