跳至主要内容
临床试验/NCT04813900
NCT04813900已完成不适用

Correlation Between Lung UltraSound Score and Hypoxemia for Interstitial Syndrome in Emergency Department

Cliniques universitaires Saint-Luc- Université Catholique de Louvain2 个研究点 分布在 1 个国家目标入组 162 人开始时间: 2021年4月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
162
试验地点
2
主要终点
The primary objective of this study is to assess the presence of a correlation between the LUSS and PaO2/FiO2 in patient presenting with IS in the ED

研究概览

简要总结

The primary objective of this study is to assess the presence of a correlation between the Lung ultrasound score (LUSS) and PaO2/FiO2 in patient presenting with interstitial syndrome (IS) in the ED. The primary end point considers the null hypothesis to be a negative linear distribution for LUSS and PaO2/FiO2 values.

Secondary objectives and secondary end points One of the secondary objectives is to assess the correlation between the LUSS and PaCO2 in patient presenting with IS in the ED. The end point of this secondary outcome considers the null hypothesis to be a positive linear distribution for the LUSS and PaCO2 values.

Another secondary objective is to determine the influence of the presence of unilateral or bilateral pleural effusion on the correlation between LUSS and PaO2/FiO2. The end point of this secondary outcome considers the null hypothesis to be a negative linear distribution for LUSS and PaO2/FiO in those three sub-groups: absence of pleural effusion group, unilateral pleural effusion group and bilateral pleural effusion group.

详细描述

Justification for the research

Interstial lung disease (ILD) is characterized by a diffuse affection of the lung interstitial tissue. It can be secondary to acute conditions such as pneumonia or pulmonary oedema either of haemodynamic aetiology either permeability induced. ILD can also result from chronic diffuse parenchymal lung disease (DPLD). It is admitted that acute ILD leads to decreased pulmonary aeration and therefore to hypoxemia.

In front of a patient presenting in Emergency Department (ED) with altered oxygen saturation, arterial blood is classically sampled. Arterial Blood Gases (ABG) procedure, in addition to be painful for the patient, is invasive. ABG however gives access, among other results, to the Arterial Pressure in Oxygen (PaO2), which evaluates the level of hypoxemia. Although the correlation between ABG results and prognosis hasn't been widely evaluated, a rather recent study supported the absence of correlation between those for Acute Heart Failure (AHF). Authors however did not report the correlation between severity of symptoms at patient's hospital admission and hypoxemia. Yet, according to the Berlin definition, hypoxemia represented by the ratio PaO2/FiO2 is a severity indicator in Acute Respiratory Distress Syndrome (ARDS).

Lung ultrasound is a simple tool, non-invasive, non-irradiating, low cost and easily available at the patient's bedside. In addition, ultrasound equipment has become wildly available in the ED and more and more portable. Simultaneously, the interest of lung ultrasound for critically ill patient has been demonstrated. The ILD ultrasonographic diagnosis is based on the presence of multiple ultrasound artefacts called B-lines. B-lines appear when the ratio between air and water is abnormal. Different anatomic substrates have been recognized as being at the origin of this ultrasound pattern. In acute pulmonary oedema the presence of B-lines is related to the presence of extra-vascular water. B-lines presence is also attributed to the thickening of sub-pleural interlobular septa. B-lines are therefore a representation of ILD and accessible using ultrasound. Additionally, more and more ultrasound machines are provided with options to quantify the number of B-lines.

Regarding the importance of B-lines and their interconnection to ILD, a score has been created to evaluate ILD. The Lung Ultrasound Score (LUSS) is based on B-lines quantitative assessment. The B-lines detection is performed in six thoracic zones bilaterally. In each zone, ultrasound lung aeration status is determined scoring from zero to four. A normal aeration of the lung with presence of A lines, persistent pleural sliding and less than three B-lines scores zero point. An ILD, resulting in moderate loss of aeration with more than three spaced B-lines, 7mm apart, scores one point. An alveolar-interstitial syndrome meaning a severe loss of aeration with coalescent B-lines, less then 3mm apart, scores two. An alveolar consolidation leading to a complete loss of aeration with an ultrasonographic tissue like pattern, scores three. A total score over thirty-six can be calculated using this method. Initially developed on an experimental model resembling various pathological conditions encountered in the critically ill, LLUS proved to be correlated to the different states of aeration of the lung. Literature findings are consistent with LUSS being an efficient tool to measure lung aeration in different intensive care situations: re-aeration antibiotics-induced in Ventilator Associated Pneumonia, assessment of PEEP-induced lung recruitment. LUSS realized during weaning trial has been showed to be able to predict of post-extubation distress. In the Intensive Care Unit (ICU), LUSS is efficient to quantify lesions and predict mortality associated with ARDS.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
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

  • Signed consent
  • >17 years old
  • Arterial Blood Gas analysis at admission
  • Lung ultrasound within 10 minutes of ABG sample

排除标准

  • Patient with pathologies leading to chronic interstitial syndrome
  • Chronic Obstructive Pulmonary Disease (COPD)
  • Lung ultrasound not feasible: pneumonectomy history, severe obesity.

结局指标

主要结局

The primary objective of this study is to assess the presence of a correlation between the LUSS and PaO2/FiO2 in patient presenting with IS in the ED

时间窗: 6 months

The primary end point considers the null hypothesis to be a negative linear distribution for LUSS and PaO2/FiO2 values.

次要结局

  • correlation between the LUSS and PaCO2 in patient presenting with IS in the ED(6 months)
  • influence of the presence of unilateral or bilateral pleural effusion on the correlation between LUSS and PaO2/FiO2(6 months)

研究者

发起方
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
申办方类型
Other
责任方
Principal Investigator
主要研究者

Dupriez Florence

Principal investigator, MD Consultant in Emergency Medicine

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

研究点 (2)

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