跳至主要内容
临床试验/NCT03846934
NCT03846934终止不适用

Positive and Quantitative Diagnosis of Pleural Effusions by Thoracic Ultrasonography in Patients With Acute Respiratory Failure in the Emergency Department

University Hospital, Limoges1 个研究点 分布在 1 个国家目标入组 167 人开始时间: 2019年12月3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
167
试验地点
1
主要终点
Clinically relevant Pleural Effusions (PE)

研究概览

简要总结

Acute respiratory failure (ARF) is a frequent reason for consulting in the Emergency Department (ED) and one of the major clinical problems prompting admission in intensive care unit. In the ED, evaluation of an ARF is mainly based on clinical examination and frontal chest x-ray performed to the patient bedside. This practice has a limited diagnostic capacity due to a lack of specificity of clinical and radiological semiology, especially in the polypathological patient. Thoracic ultrasonography provides morphological information regrouped as a syndrome (interstitial syndrome, alveolar condensation, pneumothorax) and allows the identification of pleural effusions (PE). The PE diagnosis is easy, quick, and relies on two-dimensional ultrasound imaging. Compared to CT scan, which remains the reference examination although ill-suited in the context of emergency, thoracic ultrasonography has a sensitivity and specificity greater than 90% for pleural liquid (PL) diagnosis. In addition, thoracic ultrasonography is used to assess the volume of PL, determine its nature and guide the pleural puncture with higher performance than chest x-ray. The semi-quantitative evaluation of PEs has been validated in patients with mechanical ventilation hospitalized in intensive care unit. On the other hand, few data on the prevalence and quantification of PL for hospitalized patients in ED for an ARF are currently available.

Thus, the objective of this study is to evaluate the prevalence and severity of the PL identified by thoracic ultrasonography in patients admitted to the ED for an ARF by emergency physicians with ultrasound skills recommended by the French Society of Emergency Medicine.

详细描述

Acute respiratory failure (ARF) is a frequent reason for consulting in the Emergency Department (ED) and one of the major clinical problems prompting admission in intensive care unit. In the ED, evaluation of an ARF is mainly based on clinical examination and frontal chest x-ray performed to the patient bedside. This practice has a limited diagnostic capacity due to a lack of specificity of clinical and radiological semiology, especially in the polypathological patient. Thoracic ultrasonography provides morphological information regrouped as a syndrome (interstitial syndrome, alveolar condensation, pneumothorax) and allows the identification of pleural effusions (PE). The PE diagnosis is easy, quick, and relies on two-dimensional ultrasound imaging. Compared to CT scan, which remains the reference examination although ill-suited in the context of emergency, thoracic ultrasonography has a sensitivity and specificity greater than 90% for PL diagnosis. In addition, thoracic ultrasonography is used to assess the volume of PL, determine its nature and guide the pleural puncture with higher performance than chest x-ray. The semi-quantitative evaluation of PEs has been validated in patients with mechanical ventilation hospitalized in intensive care unit. On the other hand, few data on the prevalence and quantification of PL for hospitalized patients in ED for an ARF are currently available.

Thus, the objective of this study is to evaluate the prevalence and severity of the PL identified by thoracic ultrasonography in patients admitted to the ED for an ARF by emergency physicians with ultrasound skills recommended by the French Society of Emergency Medicine.

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
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patient admitted to the ED
  • AND Age >= 18 years
  • AND affiliated or beneficiary to a social security scheme
  • AND with clinical signs of ARF:
  • Cyanosis, mottling, encephalopathy
  • Respiratory exhaustion (thoraco abdominal balancing, accessory muscle play)
  • Pulse oxygen saturation (SpO2) <92% in the air
  • AND/OR showing biological signs of ARF:
  • Arterial oxygen pressure (PaO2) <60 mmHg
  • Or PaO2 / fraction of inspired oxygen (FiO2) ratio <400.

排除标准

  • Patient moribund or for whom a limitation of the care is envisaged
  • Pregnant woman
  • Absence of exploitable ultrasound image for any reason.

结局指标

主要结局

Clinically relevant Pleural Effusions (PE)

时间窗: Day 1

Number and proportion of ARF patients for whom the thoracic ultrasonography realized in ED shows a clinically relevant PE (\> 2cm)

次要结局

  • Additional diagnostic elements(Day 1)
  • Inter-pleural distance to the inspiration(Day 1)

研究者

发起方
University Hospital, Limoges
申办方类型
Other
责任方
Sponsor

研究点 (1)

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