跳至主要内容
临床试验/NCT04204070
NCT04204070Unknown不适用

Comparing Between Ultrasound Assisted Epidural Catheter Placement Using Accuro and the Use of Ultra Sound Real Time With Acoustic Puncture Assisted Device to Confirm Epidural Space End Point

Alexandria University1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2019年8月11日最近更新:
适应症

试验速览

阶段
不适用
入组人数
100
试验地点
1
主要终点
the total time of the procedure

研究概览

简要总结

Aim of the work:

To compare the use of the Accuro ultrasound and a real time ultrasound guided epidural combined with the acoustic puncture assisted device to perform the epidural anesthesia Secondary aim is to compare the incidence of complications associated with each technique.

Patient's selection:

This study will be performed on 100 pregnant patients scheduled for normal vaginal delivery under epidural analgesia.

The sample size was calculated by taking success rate of conventional LOR to be 98% in the patients; assuming 80% power, with 95% confidence interval (CI) of two techniques and 30% margin of error.

The study protocol will be reviewed and approved by the Ethics Committee of the Alexandria Main University Hospitals.

A written consent will be obtained from all the patients participating in this study.

Complete history will be taken from all the patients and will be subjected to thorough examination and routine laboratory investigations. Patients will be randomly divided into two equal groups using a computer-generated program.

Group I consists of 50 patients scheduled for epidural catheter insertion using the Accuro ultrasound imaging assisted technique.

Group II consists of 50 patients scheduled for epidural catheter insertion using the real time ultrasound guided technique combined with the use of the acoustic puncture assist device (APAD) technique.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
20 Years 至 45 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • pregnant patients scheduled for normal vaginal delivery under epidural analgesia.

排除标准

  • • Any contraindication for epidural analgesia
  • High risk pregnancy or precious baby.
  • Patients not willing for participation.

结局指标

主要结局

the total time of the procedure

时间窗: the procedure time

( time measured from the patient is fully draped and in the proper sitting position till the end of insertion of the epidural catheter )

the depth of the EDS from skin,

时间窗: the procedure time

inmm

, the time taken for space localisation .

时间窗: the procedure time

(it is defined as time taken in seconds from skin puncture until the successful space localisation)

the number of attempts to perform the epidural anesthesia, the repositioning of the epidural needle either in the same space or in different space

时间窗: the procedure time

the number of attempts to perform the epidural anesthesia, the repositioning of the epidural needle either in the same space or in different space

次要结局

  • compare the incidence of complications associated with each technique.(the procedure time)

研究者

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

Yasser Mohamed Mohamed Osman

assistant professor of anesthesia Alexandria university

Alexandria University

研究点 (1)

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