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临床试验/NCT04412551
NCT04412551已完成不适用

Lung Ultrasound for Assessment of Patients With Moderate to Severe Covid-19

Dalarna County Council, Sweden1 个研究点 分布在 1 个国家目标入组 72 人开始时间: 2020年5月20日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
72
试验地点
1
主要终点
Identification of requirement of mechanical ventilation

研究概览

简要总结

This observational study will describe lung ultrasound (LUS) findings over time in hospitalized patients with moderate to severe Covid-19 lung disease. Our primary aim is to investigate if lung ultrasound can identify and/or predict patients requiring mechanical ventilation. Another aim is to describe LUS findings associated with clinical findings and patient condition.

详细描述

Study patients with moderate to severe Covid-19 infection will be screened with lung ultrasound daily. Lung ultrasound will be assessed by LUS-score for acute respiratory distress syndrome (ARDS) (0-36 points, Bouhemad 2015). Findings of B-line artifacts and consolidations will be noted. In addition to LUS, clinical parameters from physical examination and laboratory tests will be collected. Participants wil be followed until either admission to intensive care unit (ICU) for mechanical ventilation or until clinical improvement. A group of patients with mild Covid-19 infection will be recruited and screened once as reference.

Apart from assessment with LUS, patients are managed according to routine care.

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 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Covid-19 confirmed by positive polymerase chain reaction (PCR)
  • oxygen by mask or nasal prongs ≥ 4 l/min or high flow nasal cannula (HFNC) with fraction of inspired oxygen (FiO2) ≥ 30%
  • age between 18-80 years
  • informed consent

排除标准

  • patients subject to treatment-limitation "no ICU"
  • history of heart failure
  • history of lung disease e.g.: pneumonectomy, pulmonary fibrosis or other interstitial lung disease, pleurodesis
  • history of kidney failure requiring dialysis
  • any reason making lung ultrasound or daily follow up impossible
  • opposition to participation in the study

结局指标

主要结局

Identification of requirement of mechanical ventilation

时间窗: 3 weeks

Assessment of LUS-score or findings of consolidations correlated to requirement of mechanical ventilation on ICU

次要结局

  • Description of findings on LUS(3 weeks)
  • Prediction of requirement of mechanical ventilation(3 weeks)
  • Association of LUS to clinical parameters(3 weeks)

研究者

发起方
Dalarna County Council, Sweden
申办方类型
Other
责任方
Principal Investigator
主要研究者

Maria Hårdstedt

Dr. Maria Hårdstedt, PhD, Specialist Internal Medicine

Dalarna County Council, Sweden

研究点 (1)

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