COVIDTrach; a UK National Cohort Study of Mechanically Ventilated COVID-19 Patients Undergoing Tracheostomy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 2,234
- 试验地点
- 1
- 主要终点
- Time to wean
研究概览
简要总结
COVIDTrach aims to assess the outcomes of tracheostomy in mechanically ventilated patients with COVID-19. The use of personal protective equipment and incidence of COVID-19 amongst operators is also recorded.
详细描述
COVID-19 can lead to a severe respiratory illness with 5-12% requiring mechanical ventilation.Standard UK intensive care practice is to consider a tracheostomy after 7-10 days of mechanical ventilation in order to facilitate weaning, reduce duration of mechanical ventilation, shorten intensive care stay and reduce complications relating to prolonged presence of an endotracheal tube. Given the severity of respiratory illness and a mortality in mechanically ventilated COVID 19 patients which exceeds 50%, the benefit of tracheostomy in this group is uncertain.
There are also unique considerations regarding health care professional (HCP) safety when performing tracheostomy in COVID-19 patients due to the potential of aerosol generation and transmission of the infection. ENT UK and other organisations have issued guidance regarding surgical tracheostomy in terms of timing, environment, technique and level of personal protective equipment (PPE). The ability of hospital departments to follow this guidance and the effectiveness of these measures is unknown.
This UK national cohort study aims to assess the effects of tracheostomy in mechanically ventilated COVID-19 patients in terms of the duration of mechanical ventilation, length of ICU and hospital stay and mortality. These data will be related to COVID-19 patients who are mechanically ventilated but do not undergo tracheostomy, as captured by the UK Intensive Care National Audit and Research Centre (ICNARC).
In parallel we will collect data on the tracheostomy procedure itself and compare these to national guidance on tracheostomy in patients diagnosed with COVID-19, and on COVID-19 infections in the surgical and medical teams involved in the tracheostomy procedure.
This proposal builds upon the ongoing COVIDTrach project that has captured data on 550 COVID-19 tracheostomies from 78 NHS hospitals throughout the UK so far. COVIDTrach has successfully brought together surgical, intensive care and anaesthetic specialists to capture early timepoints following tracheostomy. Moving forward, we will work with speech and language therapists and physiotherapists to capture later stages in the patient pathway. This will provide a unique and comprehensive assessment of the role of tracheostomy in COVID-19 patients. It will lay the foundation for further much needed multidisciplinary research into the role of tracheostomy in respiratory disease beyond the COVID-19 pandemic.
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
- 否
入选标准
- •Adult patients
- •Diagnosed with COVID-19
- •Mechanically ventilated
- •Undergoing elective surgical or percutaneous tracheostomy
- •Health care professionals involved in the tracheostomy procedure (main operator and assistant)
排除标准
- •COVID-19 patients undergoing an emergency tracheostomy;
- •Patients younger than 18 years of age
结局指标
主要结局
Time to wean
时间窗: 12 months
Clinical outcome in terms of time in days from tracheostomy to successful weaning from mechanical ventilation.
次要结局
- Complications(12 months)
- Operator wellness(12 months)
- Adherence of tracheostomy procedure to national guidance(12 months)
- Length of stay(12 months)
- Mortality(12 months)
- Airway related outcomes(12 months)
