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临床试验/NCT05465837
NCT05465837已完成不适用

Comparison Between Early and Late Tracheostomy in ICU Patients Including Non-Covid and Covid Patients, an Observational Cohort Study at SQUH

Sultan Qaboos University1 个研究点 分布在 1 个国家目标入组 156 人开始时间: 2022年2月25日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
156
试验地点
1
主要终点
Mortality in Covid versus Non-Covid cases

研究概览

简要总结

Tracheostomy is commonly indicated for the patient who is requiring long period of mechanical ventilation. Patient who require mechanical ventilation for >10 days and longer mostly get tracheostomized. Tracheostomy is associated with less complications associated with endotracheal intubation. Tracheostomy is a surgical procedure whereby an external artificial opening is made in the trachea. Several techniques are used to perform tracheostomy, including the classical standard surgical procedure completed in a surgical room and the percutaneous method performed at the patient's bedside. Surgical and percutaneous procedures are usually performed by different surgical specialists such as general; thoracic; ear, nose and throat (ENT); or maxillofacial surgeons, but percutaneous procedures are usually but not exclusively performed by surgeons and intensivists.

Early tracheostomy might reduce the length of ICU stay, whereas delaying the tracheostomy might avoid a few. A review of recent studies showed a decrease in the mortality rate in early tracheostomised patients compared with late. Tracheostomy is a routine bedside procedure in ICU with minimal complications.

Severe acute respiratory syndrome (SARS) and Coronavirus 2 (SARS-CoV-2) started to appear in Oman in early February 2020, resulting in an escalation of new cases within days. In the first weeks of the pandemic, many guidelines from different specialties recommended avoiding early tracheostomy to minimize the risk of infection to clinicians.

Specifically, recommendations for tracheostomy in the current pandemic were rooted in the assumption that maximal infectivity of this novel virus occurred around day 7 to 10 after symptom onset, and performing tracheostomy at that time would endanger maximal risk to those performing it. Hence these factors interfered with the timing of Tracheostomy for Covid patients.

This is an observational cohort study. It will assess patients admitted to ICU at SQUH during the period between January 2020 and December 2021 with Non-Covid and Covid-19 patients. This study will assess the causes and outcomes of early and late tracheostomy in Non-Covid and Covid-19 patients requiring mechanical ventilation. Main outcomes will include mortality rate, ventilation days, and ICU length of stay.

详细描述

Introduction:- Tracheostomy is a common procedure for critically ill patients who require long-term mechanical ventilation (3) and have a low Glasgow coma scale and for chest toileting. Compared with an endotracheal tube, a shorter tracheostomy tube that bypasses the mouth and pharynx can avoid oropharyngeal and laryngeal complications, improve patient comfort and reduce sedative drug use.

Early versus late tracheostomy:

In one study comparing early and late tracheostomy, they included eight RCTs. Results showed moderate quality from seven RCTs and lower mortality rates in the early as compared with the late tracheostomy group. On the other hand, in another study which was a prospective observational study, the results showed that there was no difference in 3-month mortality between early and late tracheostomy.

Covid-19 is a recently emerged disease and has resulted in an increasing number of patients requiring mechanical ventilation and ICU admission. Several recommendations and guidelines have discussed when to perform a tracheostomy in COVID-19 patients, while the timing is varied across the literature. Recommendations from the UK and North America suggested that tracheostomy should be delayed until at least 14 days from endotracheal intubation to clarify prognostic information and for the viral load to sufficiently decline. On the other hand, early tracheostomy may help in early weaning (around 7-10 days))

In this study, we aimed to investigate the differences in outcomes when tracheostomy is done early versus late in covid and non-covid cases.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 88 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • • Adult ICU patients (more than 18 years old) who underwent tracheostomy in ICU.

排除标准

  • • Tracheostomy performed as part of operative management.

结局指标

主要结局

Mortality in Covid versus Non-Covid cases

时间窗: upto 90 days

30 and 60 Days mortality

次要结局

  • Ventilation days(upto 90 days)
  • ICU length of stay(upto 90 days)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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