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
- 否
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
Giovanni Volpicelli
Principal Investigator
San Luigi Gonzaga Hospital
研究点 (1)
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