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临床试验/NCT01572571
NCT01572571已完成不适用

Focused Multiorgan Ultrasound in the Emergency Evaluation of Undifferentiated Hypotension

San Luigi Gonzaga Hospital1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2011年12月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
100
试验地点
1
主要终点
Correlation between the ultrasound primary diagnosis and the clinical final diagnosis

研究概览

简要总结

Background

  • Symptomatic undifferentiated hypotension represents a negative prognostic factor and the strongest predictor of in-hospital mortality.
  • Misdiagnosis may lead to delayed or incorrect treatment of some life-threatening conditions.

Aim

  • The aim of the study is to evaluate the feasibility and accuracy of a new bedside ultrasound method that consists in the focused imaging of the thorax, abdomen and leg veins, in emergency.

Methods

  • Hypotensive (<100 mm/Hg) patients presenting to our emergency department, complaining of at least one of the neurologic, respiratory and cutaneous signs and symptoms of inadequate tissue perfusion, are prospectively studied by ultrasound-focused assessment of the heart, lungs, inferior vena cava, peritoneum, aorta and leg deep veins.
  • On the basis of physical examination and ultrasound results, the operator declares the diagnostic hypothesis without influencing the attending physician and the following diagnostic procedure (which includes ultrasound, when needed).
  • The diagnostic hypothesis is compared with the final diagnosis, obtained after the hospital route and discussed by a panel of three blinded experts (one radiologist, one cardiologist and one emergency physician).
  • The statistical agreement is calculated by the k of Cohen with p-value, confidence intervals and raw agreement (Ra).

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
16 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Arterial pressure <100 mm/Hg at presentation
  • At least one of the following symptoms:
  • Unresponsive
  • Impaired mental status
  • Respiratory distress
  • Severe malaise and fatigue

排除标准

  • Patients undergoing cardiopulmonary resuscitation
  • Trauma patients
  • Electrocardiographic and clinical diagnosis of STEMI or NSTEMI
  • Clear cause of shock that needs immediate intervention (hemorrhage, gastrointestinal bleeding, drugs overdose)
  • Late evolution of shock state in a patient already treated with known diagnostic tests

结局指标

主要结局

Correlation between the ultrasound primary diagnosis and the clinical final diagnosis

时间窗: Clinical judgment on the final diagnosis as deduced from all the data obtained after hospital stay

次要结局

未报告次要终点

研究者

发起方
San Luigi Gonzaga Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Giovanni Volpicelli

Principal Investigator

San Luigi Gonzaga Hospital

研究点 (1)

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