NCT01818882终止不适用
Evaluation of the Diagnostic Value of Portable Ultrasound for Dyspneic Patient Support in the Emergency Department: a Randomized Study
Centre Hospitalier Universitaire de Nīmes2 个研究点 分布在 1 个国家目标入组 85 人开始时间: 2014年4月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 85
- 试验地点
- 2
- 主要终点
- Length of hospital stay in days
研究概览
简要总结
The main objective of our study is to compare the effects of two care strategies for dyspneic patients on the length of hospital stay: (1) standard care (=contextual analysis + conventional clinical chest radiography) versus (2) standard care + pleuropulmonary ultrasound.
详细描述
The secondary objectives of this study are to assess the following for both arms:
A-fatality rate, B-degree of concordance between the diagnosis orientation in the emergency department and final diagnosis determined by an expert committee using patient records one month later (blind evaluation by a panel of experts) C-clinical improvement between early emergency care and later care outside the emergency department (clinical parameters = blood gases and other biological parameters) D-imaging parameters.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 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
- 否
入选标准
- •The patient must have given his/her informed and signed consent
- •The patient must be insured or beneficiary of a health insurance plan
- •Patient consulting in the emergency department for dyspnea
排除标准
- •The patient is participating in another study
- •The patient is in an exclusion period determined by a previous study
- •The patient is under judicial protection, under tutorship or curatorship
- •The patient refuses to sign the consent
- •It is impossible to correctly inform the patient
- •The patient cannot read French
- •The patient is pregnant, parturient, or breastfeeding
结局指标
主要结局
Length of hospital stay in days
时间窗: 1 month
次要结局
- Patient deceased? yes/no(1 month)
- Glasgow scale(day 3)
- Temperature(day 3)
- CO2 arterial pressure(day 3)
- O2 saturation(day 3)
- Alkaline reserve(day 3)
- hemoglobin(day 3)
- Pulmonary x-ray, yes/no(baseline, day 0)
- Diagnosis given by expert committee based on patient file(1 month)
- Heart rate(day 3)
- white blood cell count(day 3)
- C-reactive protein(day 3)
- right parenchymal origin on x-ray, yes/no(baseline, day 0)
- left pleural effusion on ultrasound, yes/no(baseline, day 0)
- right pneumothorax on ultrasound, yes/no(baseline, day 0)
- Diagnosis in the emergency room(upon discharge from the emergency department (max 1 month))
- Respiratory rate(day 3)
- Systolic blood pressure(day 3)
- Diastolic blood pressure(day 3)
- blood pH(day 3)
- right alveolar opacities on x-ray, yes/no(baseline, day 0)
- left parenchymal origin on x-ray, yes/no(baseline, day 0)
- right pleural effusion on x-ray, yes/no(baseline, day 0)
- right alveolar-interstitial syndrome on ultrasound, yes/no(baseline, day 0)
- O2 arterial pressure(day 3)
- Brain Natriuretic Peptide(day 3)
- pleuropulmonary ultrasound, yes/no(baseline, day 0)
- left alveolar-interstitial syndrome on ultrasound, yes/no(baseline, day 0)
- right lung consolidation on ultrasound, yes/no(baseline, day 0)
- left lung consolidation on ultrasound, yes/no(baseline, day 0)
- left alveolar opacities on x-ray, yes/no(baseline, day 0)
- right pleural effusion on ultrasound, yes/no(baseline, day 0)
- left pleural effusion on x-ray, yes/no(baseline, day 0)
- left pneumothorax on ultrasound, yes/no(baseline, day 0)
研究者
研究点 (2)
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