跳至主要内容
临床试验/NCT04240912
NCT04240912已完成不适用

Confirmation of Epidural Catheter Location by Epidural Pressure Waveform Recordings by the CompuFlo® Cath-Checker System in Laboring Women.

European e-Learning School in Obstetric Anesthesia1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2020年4月28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
40
试验地点
1
主要终点
occurrence of epidural pulse waves (EPW)

研究概览

简要总结

The purpose of this single arm, open label study will be to evaluate whether the dwell time of the epidural catheter, patients' position, the presence of active labor contractions and the priming volume of the epidural catheter may affect the sensitivity and specificity of CompuFlo to detect epidural pulse waveforms (EPW) to assess the correct placement of the catheter in the epidural space.

详细描述

The purpose of this single arm, open label study will be to evaluate whether the dwell time of the epidural catheter, patients' position, the presence of active labor contractions and the priming volume of the epidural catheter may affect the sensitivity and specificity of CompuFlo to detect epidural pulse waveforms (EPW) to assess the correct placement of the catheter in the epidural space.

The primary objective will be the correlation between the appearance of EPW recorded by the CompuFlo and the correct placement of the epidural catheter as assessed by the occurrence of adequate bilateral labor analgesia.

Secondary objectives will be the effects of the dwell time of the epidural catheter, patients' position, the presence of active labor contractions and the priming volume of the epidural catheter on the EPW.

The study will enroll consecutive parturients in active labor who have received effective epidural labor analgesia with an epidural catheter. After epidural catheter priming, the occurrence or the absence of EPW will be investigated.

Endpoints (quantitative measurements required by the objectives)

研究设计

研究类型
Observational
观察模型
Case Only
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

  • healthy women in active labor who received epidural analgesia

排除标准

  • healthy women in active labor who received ineffective epidural analgesia

结局指标

主要结局

occurrence of epidural pulse waves (EPW)

时间窗: up to 5 minutes

The occurrence of EPW recorded by the CompuFlo in working epidural catheters (epidural catheter which have produced epidural block)

次要结局

  • patient position(up to 10 minutes)
  • uterine contractions(up to 10 minutes)
  • valsalva(up to 10 minutes)

研究者

发起方
European e-Learning School in Obstetric Anesthesia
申办方类型
Other
责任方
Sponsor

研究点 (1)

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