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临床试验/NCT05935475
NCT05935475已完成不适用

A Comparative Study Between Electrocardiography Guided Technique Versus Anatomical Based Technique for Ideal Positioning of Dialysis Catheter Tip in Pediatric Patients

Tanta University1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2023年5月28日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
150
试验地点
1
主要终点
The ideal tip position of dialysis catheter

研究概览

简要总结

This prospective study will be conducted to compare between the efficacy of both ECG-guided technique and anatomical landmark technique to detect the ideal positioning of dialysis catheter tip and whether it will decrease the radiation exposure or no?

详细描述

This study will be conducted on 150 children and adolescents with end stage renal disease or any cause for urgent hemodialysis at our nephrology Unit at TUH during the period of the study and classified into two equal groups:

Group A (control): insertion of dialysis catheter using the anatomical landmark-guided technique.

Group B: insertion of dialysis catheter using the ECG-guided technique. Participants will be randomly assigned using an internet-based computer program (http://www.randomizer.org) either to the anatomical landmark group or to the ECG group.

All patients included in the study will be subjected to:

  1. History taking including the cause of dialysis.
  2. Clinical examination.
  3. Investigations:

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Double (Participant, Outcomes Assessor)

盲法说明

Participants will be randomly assigned using an internet-based computer program (http://www.randomizer.org) either to the anatomical landmark group or to the ECG group

入排标准

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

入选标准

  • Pediatric patients from 5 to 18 years require dialysis catheter insertion for any indication as acute or chronic renal failure.

排除标准

  • Patients with coagulopathy.
  • Patients with infection.
  • Patients with cardiac arrhythmia or pacemaker

结局指标

主要结局

The ideal tip position of dialysis catheter

时间窗: one year

all the participant will be cannulated in the right internal jugular vein by the Seldinger technique with the aid of ultrasound, In the ECG-guided technique,the wire will be withdrawn until positioned at the entry of the Superior Vena Cava in the right atrium and the P-wave returned to a normal configuration.In the anatomical landmark technique: Before insertion, the catheter depth was calculated from the insertion point to a point (midway the vertical line from the clavicular head of sternocleidomastoid to inter nipple line.An anterior-posterior CXR in supine position will be taken in all patients, to confirm the placement and positioning of the dialysis catheterThe whole length of the SVC was defined on CXR as the area from the lower border on the first right costal cartilage close to the sternum to the conventional radiographic SVC-RA junction

次要结局

  • Post insertion adverse events(one year)

研究者

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

Sara Mabrouk Elghoul

Principal Investigator, Clinical lecturer of Pediatric Nephrology

Tanta University

研究点 (1)

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