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OpenTrials
Completed

NCT Number: NCT04417790

Utility of Lung Ultrasound in the Estimation of Extravascular Lung Water in Pediatric Population

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.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Lung ultrasound and EVLW measurement by transpulmonary thermodilution.

Diagnostic Test

Lung ultrasonography by 8 Quadrant protocol of Volpicelli et al. Transpulmonary thermodilution for extravascular lung water measurement

Primary outcomes

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

    Time frame: Till extubation or second post-operative day.

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

    Time frame: Till extubation or second post-operative day.

Secondary outcomes

  1. trending ability of lung USG B-line score to predict PICCO derived EVLW / EVLWI in pediatric cardiac surgical patients.

    Time frame: Till extubation or second post-operative day.

Sponsors and collaborators

Lead sponsor

Post Graduate Institute of Medical Education and Research, Chandigarh

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Jun 5, 2020
Registry last updated
Sep 14, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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