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临床试验/NCT04095117
NCT04095117招募中不适用

Evaluation of Sagittal Abdominal Diameter as a Predictor of the Skin to Epidural Space Distance in Obese Patients

Ain Shams University1 个研究点 分布在 1 个国家目标入组 135 人开始时间: 2019年7月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
135
试验地点
1
主要终点
Accuracy of the sagittal abdominal diameter for prediction of the skin to epidural space distance

研究概览

简要总结

The aim of this study is to evaluate the use of the sagittal abdominal diameter (SAD) as a potential predictor of the skin to epidural space distance (SESD) and to compare its accuracy versus that of the BMI as a previously validated predictor

详细描述

Adult patients from either sex with BMI from 30-39.9 kg/m², scheduled for lower abdominal operations or surgeries on the lower extremities under epidural anesthesia will be eligible. Pregnant women will be excluded.

The sagittal abdominal diameter (SAD), which is the anteroposterior diameter of the abdomen in the supine position at L4-5 level will be measured in all subjects along with the BMI prior to epidural placement.

The epidural space will be accessed at the L3-L4 or L4-L5 interspace with a 16-G or 18-G Tuohy needle using a loss of resistance to saline technique. The proper placement of the needle in the epidural space will be confirmed by connecting the hub of the epidural needle via a rigid extension tubing to a saline filled pressure transducer to demonstrate the characteristic epidural space pressure wave changes described by Arnuntasupakul and his colleagues (2016), which is a pulsatile waveform synchronized with arterial pulsations.

The distance from skin to epidural space will be marked on the needle with a sterile marker and will be recorded.

An epidural catheter will be passed into the epidural space and the epidural block will be activated in the usual way until adequate sensory and motor block is established in both lower extremities (Bromage score 3-4).

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age 18 years or older
  • BMI 30 to 39.9
  • Either sex
  • Elective surgery on lower extremities performed under epidural anesthesia

排除标准

  • Pregnant women
  • Contraindications to epidural block

结局指标

主要结局

Accuracy of the sagittal abdominal diameter for prediction of the skin to epidural space distance

时间窗: 18 months

Actual skin to epidural space distance will be determined and regressed on the sagittal abdominal diameter to determine accuracy of the latter for prediction of the former

次要结局

  • Accuracy of the BMI for prediction of the skin to epidural space distance(18 months)

研究者

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

Sameh M. Hakim

Professor of Anesthesiology, Intensive Care and Pain Management

Ain Shams University

研究点 (1)

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