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临床试验/NCT01012518
NCT01012518Unknown不适用

Video-guided Percutaneous Tracheostomy (PCT): Evaluating the Safety, Efficacy and Simplicity of a Novel Technique, Compared to Conventional PCT

Tel-Aviv Sourasky Medical Center2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2010年1月最近更新:
适应症

试验速览

阶段
不适用
入组人数
60
试验地点
2
主要终点
procedure-related complications

研究概览

简要总结

The purpose of this study is to compare the feasibility, safety, efficacy and ease of performance of a video-assisted PCT (via an endotracheal tube embedded with a mini video-camera) with the standard ("blind") PCT technique.

详细描述

Background

Percutaneous tracheostomy (PCT) is commonly used in critically-ill patients who require long-term mechanical ventilation in the intensive care unit (ICU). While being effective and safe, this technique has some complications. These include paratracheal insertion of the tracheostomy tube, tracheal injury; puncturing the cuff and transfixing the endotracheal tube (ETT) during the transtracheal needle insertion; inserting the guide wire through Murphy's eye; or accidental extubation while withdrawing the endotracheal tube during the procedure leading to loss of the airway [1-6].

Although using the fingertip to palpate the trachea and endotracheal tube is a useful technique to locate the tip of the endotracheal tube during the procedure, it is unreliable, particularly in patients with short and thick necks. There are reports of lower rates of acute complications under endoscopic (bronchoscopic) guidance [7-11]. However, there is no adequate controlled study showing that endoscopic-guided tracheostomy is superior to the 'blind' one. Moreover, it is an expensive tool which is not readily available in some centers.

Video guidance provides a cost-effective alternative to bronchoscopes, that may also reduce the risk of procedure-related complications such as paratracheal insertion of the tracheostomy tube, tracheal injury or cuff puncture [12].

The goal of this study is to evaluate the safety, efficacy and operability of video-guided PCT compared with standard PCT. Video-guided PCT, a bedside safe and simple technique that can be performed in the ICU without the assistance of a pulmonologist, may overcome some of the limitations of the standard percutaneous tracheostomy.

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
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • The investigators will enroll for this study
  • patients aged >18 years old, admitted to the ICU,
  • who require elective PCT for prolonged mechanical ventilation, airway protection or weaning failure.

排除标准

  • Patients indicated for surgical tracheostomy, due to altered or difficult local anatomy;
  • necessity of emergency airway access due to acute airway compromise;
  • evidence of infection in the soft tissues of the neck;
  • coagulation abnormalities (INR>1.5, PTT>40, thrombocyte count < 50,000);
  • gross distortion of the neck anatomy (due to hematoma/tumor/thyromegaly/scarring from previous neck surgery/ unstable C-spine);
  • contra-indication for re-intubation/suspected loss of airway during re-intubation; hemodynamic instability.

结局指标

主要结局

procedure-related complications

时间窗: 6h

次要结局

  • operative time(minutes)

研究者

申办方类型
Other Gov

研究点 (2)

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