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临床试验/NCT04978155
NCT04978155已完成不适用

Usefulness of Doppler Ultrasound Carried Out by the Vascular Surgeon After Loco-regional Anesthesia for Preferred Access

University Paul Sabatier of Toulouse1 个研究点 分布在 1 个国家目标入组 193 人开始时间: 2020年1月1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
193
试验地点
1
主要终点
Functionality of the AVF at the time of the postoperative

研究概览

简要总结

Preoperative vascular mapping with echo-Doppler is acknowledged as indispensable to create an arteriovenous fistula for haemodialysis (AVF). The conditions for performing this examination are not always ideal (venous vasospasm in cool temperatures, variability of the volume status in the dialysis patient).

On the other hand, the use of a loco-regional anaesthesia (LRA) results in the vasodilation of the limb thus rendering it possible to use the veins which were initially considered too small.

The aim of this study is to assess the functionality of our AVF when ultrasound identification was used by the surgeon after the LRA. These results have been compared with those of the preceding year during which this identification was not implemented.

详细描述

The investigators conducted a prospective study in the year 2020 during which all the patients (n=90) had an AVF creation with preoperative venous identification by the surgeon at university hospital of TOULOUSE (France)(echo group).

All the patients gave their consent, and the database was anonymised upon completion.

All patients were seen in a preoperative consultation with venous mapping carried out by a physician specialised in the use of Doppler ultrasonography. Following this consultation, a type of fistula was programmed in accordance with the Silva criteria (notably a vein with a diameter of over 2.5mm and an artery of 2mm). On the day of the operation, loco-regional anaesthesia was performed under sonographic guidance according to the previous description . The decision of the block approach and the choice of local aesthetic agent was left to the discretion of the anaesthesiologist.

The surgeon carried out an ultrasound and modification of the type of AVF was then made if the Silva criteria differed from those described during initial consultation. The modification could be a more distal creation, a more proximal creation, a change of vein or a change of artery.

The investigators succeeded to create more distal AVF when the vein had a diameter of over 2.5mm after LRA. Furthermore, the investigators reassembled the AVF when the vein appeared too small or residual (for example, following the attachment of an infusion having occurred between mapping and the surgery).

研究设计

研究类型
Observational
观察模型
Case Control
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

  • Native AVF access
  • During the year 2020
  • Preoperative mapping during the consultation
  • Loco-regional anesthesia

排除标准

  • Redo surgery

结局指标

主要结局

Functionality of the AVF at the time of the postoperative

时间窗: 6 weeks

An AVF is defined as functional if all the criteria of the good development of the haemodialysis access (based on the National Kidney Foundation's criteria) are present : Blood flow\>600ml, diameter over 6mm and lower depth of 6mm

次要结局

  • The rate of planning change between the surgical project at the time of the consultation and the AVF that is finally placed(During the surgery)
  • Primary, assisted primary and secondary permeability of our accesses(12 months)

研究者

发起方
University Paul Sabatier of Toulouse
申办方类型
Other
责任方
Principal Investigator
主要研究者

Aurélien Hostalrich

Vascular Surgeon,MD, Principal investigator

University Paul Sabatier of Toulouse

研究点 (1)

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