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临床试验/NCT04642703
NCT04642703Unknown不适用

Mortality in Patients With Severe SARS-CoV-2 Pneumonia Who Underwent Tracheostomy Due to Prolonged Mechanical Ventilation

University of Chile1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2020年3月3日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
100
试验地点
1
主要终点
90-days mortality rate

研究概览

简要总结

Background: Invasive mechanical ventilation (IMV) in COVID-19 patients has been associated with a high mortality rate. In this context, the utility of tracheostomy has been questioned in this group of ill patients. This study aims to compare in-hospital mortality in COVID-19 patients with and without tracheostomy due to prolonged IMV Methods: Cohort study of adult COVID-19 patients subjected to prolonged IMV. Since the first COVID-19 case (March 3, 2020) up to November 30, 2020, all adult critical patients supported with IMV by 10 days or more at the Hospital Clínico Universidad de Chile will be included in the cohort. Pregnant women and non-adult patients will be excluded. Baseline characteristics, comorbidities, laboratory data, disease severity, and ventilatory support will be retrospectively collected from clinical records. The indication of tracheostomy, as part of our standard of care, will be indicated by a team of specialists in intensive care medicine, following national guidelines, and consented to by the patient's family. The 90-days mortality rate will be the primary outcome, whereas IMV days, hospital/CU length of stay, and the frequency of healthcare-associated infections will be the secondary outcomes. Also, a follow-up interview will be performed one year after a hospital discharged in order to assess the vital status and quality of life.

The mortality of patients subjected to tracheostomy will be compared with the group of patients without tracheostomy by logistic regression models. Furthermore, propensity-score methods will be performed as a complementary analysis.

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

  • COVID-19 confirmed case
  • Invasive mechanical ventilation by 10 days or longer

排除标准

  • Childhood
  • Pregnant women

结局指标

主要结局

90-days mortality rate

时间窗: Since mechanical ventilation onset to death or 90-days follow-up

Death occurred during the follow-up

次要结局

  • ICU length of stay(From first ICU admission to transfer at a lower complexity unit, up to 90 days)
  • Time of mechanical ventilation(From orotracheal intubation to mechanical ventilation extubation (weaning), up to 90 days)
  • Health-care associated infections(From hospital admission to discharge, up to 90 days)
  • Long-term quality of life assessed by Short Form-36 Health Survey, SF-36(One year after hospital discharge)
  • Hospital length of stay(From hospital admission to discharge, up to 90 days)

研究者

发起方
University of Chile
申办方类型
Other
责任方
Principal Investigator
主要研究者

Carlos Romero, MD.

Medical Chief, Intensive Care Unit, Hospital Clínico Universidad de Chile

University of Chile

研究点 (1)

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