跳至主要内容
临床试验/NCT05792098
NCT05792098Enrolling By Invitation不适用

Percutaneous Dilatational Tracheostomy and Thyroid Isthmus Penetration

Charles University, Czech Republic2 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2023年4月6日最近更新:
适应症

试验速览

阶段
不适用
状态
Enrolling By Invitation
发起方
入组人数
200
试验地点
2
主要终点
The guidewire penetration through the thyroid isthmus.

研究概览

简要总结

A prospective randomized interventional study will be conducted in the Military University Hospital Prague at the department of Anesthesiology and Intensive care. The incidence of thyroid isthmus penetration will be evaluated during percutaneous dilatational tracheostomy in two groups (ultrasound-guided puncture vs. standard approach using only anatomical landmarks).

详细描述

A prospective randomized interventional study will be conducted in the Military University Hospital Prague at the department of Anesthesiology and Intensive care. Patients indicated by the attending physician to percutaneous dilatational tracheostomy (PDTS) due to long-term need for mechanical ventilation will be randomly divided into two groups. The standard procedure group will undergo PDTS by the attending physician in the standard manner based on clinical examination and anatomical landmarks using bronchoscopic navigation. In the second group, the attending physician will additionally use ultrasound navigation during the procedure. After insertion of the guidewire, before dilation is performed, patients in both groups will be examined by ultrasound by an independent physician - the study investigator - who will verify the position of the guidewire and its relationship to the surrounding structures. In case of malposition of the guidewire (unacceptable lateral or craniocaudal), the penetration site will be adjusted and the PDTS completed.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
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

  • 18 Years and older
  • long-term need for mechanical ventilation

排除标准

  • not willing to participate

结局指标

主要结局

The guidewire penetration through the thyroid isthmus.

时间窗: During procedure

Incidence of guidewire penetration through the thyroid isthmus in standard and ultrasound navigated percutaneous dilatational tracheostomy.

Monitoring the incidence of early postoperative complications.

时间窗: Up to 10 days

The incidence of bleeding from tracheostomy canal during hospitalization depending on guidewire position, defined as the need for any intervention to stop the bleeding. The incidence of tracheostomy canal infection during hospitalization depending on guidewire position, defined as the presence of any clinical signs of inflammation (swelling, redness, pain, secretion production, dehiscence).

次要结局

  • Using ultrasound examination as a tool for PDTS navigation in terms of correct puncture site.(During procedure)

研究者

发起方
Charles University, Czech Republic
申办方类型
Other
责任方
Sponsor

研究点 (2)

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