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临床试验/NCT04660448
NCT04660448已完成不适用

Lung Ultrasound Score and Pediatric Intensive Care Outcomes: a Prospective Observational Multicenter Study

Fundación para la Investigación Biosanitaria del Principado de Asturias1 个研究点 分布在 1 个国家目标入组 650 人开始时间: 2020年12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
650
试验地点
1
主要终点
Requirement of invasive mechanical ventilation for more than 96 hours

研究概览

简要总结

Bedside lung ultrasonography helps to obtain reliable clinical information about lung aeration, that has been categorized by means of the so-called lung ultrasound score (LUS). In critically ill adults, LUS has been related with the outcome both in patients with respiratory and some non-respiratory conditions. Pediatric studies about lung aeration have been done mainly on postoperative cardiac patients and infants with bronchiolitis. In this prospective, observational, multicenter, feasibility and diagnostic accuracy study, we will explore the degree of lung aeration impairment as a potential outcome predictor in critically ill children with a variety of underlying conditions. Children from 1 month to 18 years of age admitted to PICU will be recruited and LUS will be calculated at two time points: at 12 ± 6 hours and at 48-72 hours. Univariate and multivariate statistical analysis will be performed in order to ascertain the outcome influence of clinical factors in general and LUS in particular.

详细描述

Lung aeration can be assessed at the bedside by means of lung ultrasound, a non-invasive, quick, simple, and reproducible technique. It provides semiquantitative information about the amount of extravascular lung water (EVLW), which correlates with lung aeration. Accumulation of EVLW occurs secondarily to acute lung injury due to infection, inflammation or fluid overload. Lung aeration, measured by the lung ultrasound score (LUS), has been associated to patients' outcome in several studies in adult patients, suggesting that critically ill subjects showing higher degree of aeration loss have a worse outcome. This fact has been shown not only in patients with baseline respiratory conditions (for example in severe acute respiratory syndrome coronavirus 2), but also in adults with non-respiratory conditions, such as shock and in high-risk postoperative patients. Furthermore, animal studies have suggested that information obtained through lung ultrasonography may precede clinical signs and could help anticipate focused treatment.

To date, pediatric studies addressing the potential relationship between LUS and the outcome of critically ill children are scarce and limited to postoperative cardiac patients and infants with bronchiolitis.

In our research, children from 1 month to 18 years of age admitted to pediatric intensive care unit (PICU) who fulfill inclusion criteria will be recruited and will undergo point of care lung ultrasound examination at 12 ± 6 hours and at 48-72 hours from admission. Clinical data will be recorded and LUS will be calculated. The main objective of our study is to assess the potential role of LUS (as a semiquantitative indicator or lung aeration) as a feasible and reliable outcome prediction tool in children admitted to PICU. Secondary objectives will include to analyze the correlations between LUS and the need and length of ventilatory support, inflammatory and cardiac markers, hydric balance, renal replacement therapies requirement, and validated prognostic scales, as well as age, underlying disease, co-morbidities, length-of-stay, and other clinical characteristics of included children.

Patients with acute respiratory distress syndrome (ARDS) or shock during PICU admission time will also undergo additional lung ultrasound examinations at 12 ± 6 hours and at 48-72 hours from ARDS or shock diagnosis, as these subgroups represent a very specific and severe cohort of patients, which merits further analysis.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

入排标准

年龄范围
1 Month 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Children 1 month to 18 years-old admitted to PICU due to an acute condition

排除标准

  • Children admitted to PICU to perform a procedure or to adjust a certain treatment (eg, home ventilatory support).
  • Children with chronic pulmonary pathology (cystic fibrosis, bronchopulmonary dysplasia, etc...)
  • Preoperative admissions in a stable condition (eg. Patient admitted previously to cardiac surgery)
  • Inability to obtain interpretable ultrasonographic images due to bad ultrasonographic window
  • Non disponibility of investigator
  • High frequency ventilation
  • Lack of clinical data

结局指标

主要结局

Requirement of invasive mechanical ventilation for more than 96 hours

时间窗: 96 hours

To evaluate the correlation of LUS obtained in the first 72 hours of admission with the need of invasive ventilatory support for over 96 hours. A comparison between patients with a respiratory condition versus non-respiratory condition as the cause of admission will be performed.

次要结局

  • Correlation between lung aeration and hydric balance and the need of renal replacement therapy(72 hours)
  • Comparison of LUS calculation exploring 12 areas versus 8 areas(72 hours)
  • Correlation between lung aeration and bedside inflammatory markers(72 hours)
  • Correlation between LUS and pediatric mortality scales(72 hours)
  • Correlation between lung aeration and bedside cardiac markers(72 hours)

研究者

发起方
Fundación para la Investigación Biosanitaria del Principado de Asturias
申办方类型
Other
责任方
Sponsor

研究点 (1)

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