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临床试验/NCT04496076
NCT04496076已完成不适用

Severe Neurologic Injury Outcomes During COVID-19 Crisis

University of Pittsburgh1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2020年4月2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
300
试验地点
1
主要终点
In-hospital Mortality

研究概览

简要总结

A prospective cohort minimal risk study to determine the impact of the COVID-19 crisis on outcomes of neurologically injured ICU patients.

详细描述

COVID 19 pandemic has overwhelmed healthcare capacity in many regions around the world. As resources become more limited and we have to triage /ration ventilators, neurologically injured ICU patients without COVID 19 but with respiratory insufficiency may be triaged to no ventilator care due to their perceived or actual prognosis. This may lead to increased rates of withdrawal of care and mortality. Some neurologically injured ICU patients with respiratory insufficiency may be simultaneously infected with COVID 19. Their outcomes are completely unknown. Capturing data on the prevalence of limitation of care and prognosis in this patient population will provide important information towards ongoing efforts in patient care and resource utilization as we face the rapidly evolving COVID 19 pandemic. Given the expected strain on ICU resources and limitations in research in ICUs during COVID 19 pandemic, data capture/study design must be targeted and pragmatic. This study is designed to answer the most basic and important questions while minimizing the burden of data collection on already overloaded providers.

This study design is comprised of two components: Component 1- Prospective cohort prevalence study captures data related to treatments offered, limitations of care and patient outcome in 5 select primary neurological diagnoses requiring ICU care. Component 2- Case control study captures the same data elements in the same patient populations during the 3 months prior COVID 19 pandemic (Sept - Dec, 2019).

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

入选标准

  • Patients greater than or equal to 18
  • Patients who require critical care with primary diagnoses of: Acute ischemic stroke (AIS), acute intracerebral hemorrhage (ICH), acute subarachnoid hemorrhage (SAH), acute traumatic brain injury (TBI), status epilepticus (SE) patients requiring critical care

排除标准

  • Patients under the age of 18 years old
  • Pre-existing Do Not Resuscitate (DNR), Do Not Intubate (DNI), or Comfort Measures Only (CMO) status prior to acute hospitalization
  • Neurologically morbid-bound on hospital arrival (bilateral fix/dilated pupils, catastrophic bleed/TBI) and likely to progress to brain death within 48 hrs

结局指标

主要结局

In-hospital Mortality

时间窗: At hospital discharge, approximately 1 month

30-day mortality

时间窗: 30 days post-hospital discharge

次要结局

  • Limitations of patient care- Frequency of care not being provided(During In-hospital course, up to 1 month)
  • Limitations of patient care- Conversion of DNR/DNI/CMO status(During In-hospital course, up to 1 month)

研究者

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

Sherry Hsiang-Yi Chou

Associate Professor

University of Pittsburgh

研究点 (1)

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