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临床试验/NCT04689724
NCT04689724已完成不适用

Determining Airway Management Related Outcomes in COVID19 Patients and in Health Care Providers

University Health Network, Toronto1 个研究点 分布在 1 个国家目标入组 123 人开始时间: 2020年8月10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
123
试验地点
1
主要终点
Serious adverse events at intubation

研究概览

简要总结

The study has a retrospective and a prospective component. The retrospective component aims to review data of all airway management related SAEs in COVID 19 patients (between April and July 2020); hypoxemia, hypotension and cardiac arrest within 15 min of intubation. The prospective component aims to assess the incidence of COVID-19 infection in Airway Management Team members by means of an interview assessing their COVID19 status after participating in airway management in the period outlined above. This prospective interview component is starting in December 2020.

详细描述

Approximately 5-10% of all patients affected by COVID-19 develop severe respiratory distress. This has already involved hundreds of people in Ontario and thousands worldwide. In this situation, support with a mechanical ventilator is required. The first essential step to provide this support is to insert a breathing tube in the patent's trachea (windpipe), a process called 'endotracheal intubation' or more broadly, 'airway management'. While a fundamental lifesaving resource, endotracheal intubation in COVID-19 patents is a highly specialized procedure that carries risk both to patents and attending healthcare providers as follows. a) Clinicians involved in airway management for patients with coronaviruses are at extremely high risk of infection due to aerosol and droplet exposure during the procedure. b) Rapid administration of drugs that put the patent to sleep is usually required for prompt and safe endotracheal intubation. However, in physiologically compromised patents, life-threatening side-effects may occur, such as very low oxygen levels (in as many as 70% of patients), low blood pressure (18-22% of patients), and cardiac arrest (2%); these can significantly affect outcomes. No definitive data are presently available to accurately quantify the risk posed by such procedures to healthcare professionals and patents, nor the associated factors. We have developed a retrospective study reviewing data all airway management related SAEs in COVID 19 patients (between April and July 2020); hypoxemia, hypotension and cardiac arrest within 15 min of intubation. Additionally, we are going to prospectively interview Airway Management Team members that were involved in the airway management of COVID19 patients in the period described above, in order to assess whether they developed signs and symptoms and/or a confirmed COVID19 infection. This prospective interview component is starting in December 2020.

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • All Suspected or confirmed Covid-19 patients that require intubation Health care workers from the airways management team who performed an intubation on confirmed or suspected Covid-19 patients

排除标准

  • Lack of Health Care Provider Consent

结局指标

主要结局

Serious adverse events at intubation

时间窗: within 15 min of intubation

hypoxemia, hypotension and cardiac arrest within 15 min of intubation in confirmed or suspected COVID-19 patients

次要结局

  • Signs, symptoms or confirmed COVID19 infection in healthcare providers(within 14 days after participating in airway management for confirmed or suspected COVID-19 patients)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Matteo Parotto

Dr. Matteo Parotto

University Health Network, Toronto

研究点 (1)

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