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临床试验/NCT06002178
NCT06002178已完成不适用

Ultrasound Evaluation of the Vascular Anatomy of the Neck to Minimize the Accidental Risk of Vascular Puncture During Percutaneous Tracheostomy

University of Padova1 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2023年8月14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
500
试验地点
1
主要终点
Mapping of artery and veins of the neck in the general population

研究概览

简要总结

Tracheostomy is a commonly performed procedure in Intensive Care and its incidence tends to increase over time as a consequence of the increase in chronic diseases and the average age of the population accessing Intensive Care.

Surgical open tracheostomy (ST) is the standard procedure but has a relatively high incidence of peristomal infections and perioperative bleeding. Percutaneous dilatational tracheostomy (PDT) was introduced in 1985 and has since become a common bedside procedure. Compared to open ST, PDT has the advantages of a lower risk of wound infection, lower bleeding-related mortality, shorter procedure times, and improved cost-effectiveness.

Fiberoptic bronchoscopy is commonly used during PDT to verify the safety of direct tracheal access [5]. However, bronchoscopy-guided PDT has several limitations regarding the precise identification of cervical anatomical structures and the prevention of complications such as vascular injury.

Preliminary ultrasound examination of neck anatomy has numerous potential benefits, including increased safety during the procedure, identification of cervical vascularization, and localization of the tracheal puncture site with lower risk of complications [6-8]. Several studies have shown that the use of ultrasound in a preliminary and real-time manner can improve first-pass success rate and puncture accuracy, reduce procedure time, and complications.

The objective of this study is to map the arterial and venous vascular anatomy of the neck in order to identify points with a lower risk of vascular injury during PDT. This helps prevent bleeding during tracheostomy, which is one of the major complications associated with the procedure.

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

  • Patients of eighteen years or older
  • Informed consent

排除标准

  • Tracheostomized patients

结局指标

主要结局

Mapping of artery and veins of the neck in the general population

时间窗: through study completion, an average of 1 year

Described as the size of veins and arteries in the neck

Size of artery and veins of the neck in the general population

时间窗: through study completion, an average of 1 year

Described as the size of veins and arteries in the neck

次要结局

未报告次要终点

研究者

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

Alessandro De Cassai

Principal Investigator

University of Padova

研究点 (1)

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