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临床试验/NCT04417790
NCT04417790已完成不适用

Utility of Lung Ultrasound in the Estimation of Extravascular Lung Water in Pediatric Population- a Prospective Observational Study

Post Graduate Institute of Medical Education and Research, Chandigarh1 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2019年8月10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
25
试验地点
1
主要终点
cutoffs for lung USG B-line score to Predict abnormal EVLWI values.

研究概览

简要总结

Increased extravascular lung water (EVLW) may increase mortality and morbidity in cardiopulmonary pathology. Many factors can cause increased extravascular lung water and pulmonary edema after cardiac surgery. This includes left ventricular failure, acute mitral regurgitation; systemic inflammatory response post-cardiopulmonary bypass, left to right shunts, transfusion associated acute lung injury, acute respiratory distress syndrome(ARDS) and sepsis.

The clinical assessment of lung water ranges from auscultation to radiological methods to invasive measurements like dye dilution or thermodilution studies.

Lung ultrasonography is the newest modality for noninvasive assessment of extravascular lung water. Lung ultrasound has been validated against auscultation, chest X-rays, CT chest as well as the bedside gold standard, transpulmonary thermodilution in adults.

Critically ill children are more susceptible to complications and worsened outcomes from increased EVLW.

Lung ultrasound correlates with clinical and radiological endpoints, but has not been validated against invasive objective measures like transpulmonary thermodilution.

Evaluation of transpulmonary thermodilution setups in the pediatric population has shown different normal values and cutoffs compared to adults, possibly due to differential rates growth and development.

It is aimed to investigate the correlation of Lung ultrasound based indices of extravascular lung water to invasive measures, assess optimum cutoffs to appropriate clinical endpoints and evaluate their sensitivity and specificity.

研究设计

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

入排标准

年龄范围
1 Year 至 12 Years(Child)
性别
All
接受健康志愿者

入选标准

  • aged under 12 years,
  • undergoing elective cardiac surgery for cyanotic or acyanotic congenital heart disease,
  • Aristotle score ≤9,
  • with prior written informed consent

排除标准

  • Neonates,
  • Children with any chest wall deformity,
  • children with known lung disease, active infection,
  • those weighing less than 3.5 kg.

结局指标

主要结局

cutoffs for lung USG B-line score to Predict abnormal EVLWI values.

时间窗: Till extubation or second post-operative day.

correlation of lung USG B-line score with PICCO derived EVLW / EVLWI in pediatric cardiac surgical patients.

时间窗: Till extubation or second post-operative day.

次要结局

  • trending ability of lung USG B-line score to predict PICCO derived EVLW / EVLWI in pediatric cardiac surgical patients.(Till extubation or second post-operative day.)

研究者

发起方
Post Graduate Institute of Medical Education and Research, Chandigarh
申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr. Subhrashis Guha Niyogi

Fellow, Cardiac Anaesthesia

Post Graduate Institute of Medical Education and Research, Chandigarh

研究点 (1)

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