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临床试验/NCT05343442
NCT05343442已完成4 期

A Novel Technique for Safe Blind Percutaneous Tracheostomy

Alexandria University2 个研究点 分布在 1 个国家目标入组 386 人开始时间: 2021年12月19日最近更新:
适应症

试验速览

阶段
4 期
状态
已完成
入组人数
386
试验地点
2
主要终点
Percutaneous tracheostomy procedure

研究概览

简要总结

Description of a technical modification of percutaneous tracheostomy that involves a safety method for confirming the intratracheal location of the needle at the time of puncture, with preventing serious complications such as false passage or damage to the posterior tracheal wall, without coadjuvant technique

详细描述

Introduction:

Tracheotomy is one of the most common procedures used in the Intensive Care Unit (ICU). Since 1985, percutaneous tracheotomy (PT) has gained widespread acceptance as a method for creating a surgical airway, and new techniques for PT have been developed. Furthermore, the technique could be performed at the patient bedside, leading to a new way of viewing surgical access to the airway in the critically ill patient.

In 1985, Ciaglia described percutaneous dilatational tracheotomy (PDT). Five years later Griggs introduced tracheotomy using guidewire dilating forceps (GWDF). With this technique, the tracheostoma is opened using blunt-tipped forceps previously advanced over the metal guide in the tracheal lumen. In 1998 the classical technique of Ciaglia was modified using a single dilator with respect to the original technique, this modification offered the advantage that the stoma is produced by a single dilatation, thereby avoiding the need for successive dilatations.

PDT heralds many peri-procedural complications as bleeding, difficulty to place the tube, false passage, posterior tracheal wall injury, pneumothorax, pneumomediastinum, and subcutaneous emphysema. In view of preventing serious complications, fibro-bronchoscopy is the most widely used safety method, though its application as a routine coadjuvant technique is a subject of controversy, since the endoscopic guide produces a rise in airway pressure, hypoventilation, and an increase in intracranial pressure; a situation that contraindicates its utilization in some patients. Moreover, bronchoscopy increases the cost of the procedure. Capnography is useful for confirming the intratracheal location of the needle at the time of puncture. The disadvantage of capnography is the lack of direct visualization of the precise position of the needle and metal guide within the trachea. Ultrasound is a noninvasive procedure and can be useful for locating aberrant vascular structures.

One of the main advantages of percutaneous tracheotomy is bedside performance, thus eliminating the hazards, expenses, and logistics involved in operating room set-up usually required for open surgical tracheotomies. So, searching for a safe way without coadjuvant techniques is reasonable. Of note that a lot of ICUs don't have bronchoscopy or ultrasound machines routinely available. Aim of this study was to describe a novel technique for safe blind percutaneous tracheotomy without assisting tools.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

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

  • Clinical indication for tracheostomy

排除标准

  • Age <18, patients with severe coagulopathy, and unsuitable anatomy (e.g., previous cervical surgery, cervical trauma, or tumors).

结局指标

主要结局

Percutaneous tracheostomy procedure

时间窗: 7 days

Novel technique time: which is the time from tracheal tube puncture till J-guidewire insertion into the trachea

次要结局

  • Complications of the procedure(7 days)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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