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临床试验/NCT04791241
NCT04791241已完成不适用

Evaluation of a Check-list Including Lung Ultrasound for the Management of Patients With Acute Respiratory Failure at the Emergency Department During the COVID-19 Era

Centre Hospitalier Metropole Savoie6 个研究点 分布在 1 个国家目标入组 105 人开始时间: 2021年3月3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
105
试验地点
6
主要终点
Agreement between the etiology retained after using the checklist and the diagnosis retained by an adjudication committee after analysis of the entire patient file.

研究概览

简要总结

The aim of the study is to evaluate if a check-list including lung ultrasonography can help to identify the etiology of the acute respiratory failure of patients managed at the emergency room.

Adult patients admitted to the emergency room for acute respiratory failure will be offered the study. The emergency physician will perform a systematic examination using a checklist, including pulmonary embolism prediction scores, structured clinical examination and lung ultrasound, in order to establish a diagnostic hypothesis.

A diagnostic hypothesis will be made after completion of the checklist. The emergency physician can perform additional examinations and treatment after completion of the checklist.

The final diagnosis will be checked by an adjudication committee which will have all the documents established during the emergency room consultation and any hospitalization following this hospitalization.

The main outcome will be the concordance rate between the diagnosis after the check-list and the final diagnosis.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

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

  • Patient with acute respiratory failure table (SpO2 90% in ambient air or need more than 3 L/min of oxygen to have SpO2 > 92% AND/OR signs of respiratory struggle sign AND/OR respiratory rate control > 25 cycles/minute AND/OR cyanosis)
  • Over 18 years old

排除标准

  • Pregnant, Parturising or Breastfeeding Women
  • Patient who has already participated in the study in the previous 7 days

结局指标

主要结局

Agreement between the etiology retained after using the checklist and the diagnosis retained by an adjudication committee after analysis of the entire patient file.

时间窗: 1 month after inclusion

The adjudication committee will meet all 35 inclusions to determine the diagnosis of each patient after analysis of the complete anonymized file which will be provided by locol investigator one month after inclusion.

次要结局

  • Comparison of treatments introduced after completion of the checklist and after the other additional examinations performed at the emergency room(at one day)
  • Collection of additional examinations possibly performed in the emergency unit after the completion of the checklist(at one day)
  • Analysis of the diagnosis retained after the checklist in patients with a final diagnosis of COVID-19; analysis of the final diagnosis in patients with a diagnosis of COVID-19 evoked after the checklist(One month after inclusion)
  • Collection of treatments started only after completion of the checklist and verification of its suitability for the diagnosis selected(at one day)
  • Delay between completion of the checklist and obtaining the results of any other examinations(At one day)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (6)

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