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Clinical Trials/NCT04417790
NCT04417790
Completed
Not Applicable

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 site in 1 country25 target enrollmentAugust 10, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Pulmonary Congestion
Sponsor
Post Graduate Institute of Medical Education and Research, Chandigarh
Enrollment
25
Locations
1
Primary Endpoint
cutoffs for lung USG B-line score to Predict abnormal EVLWI values.
Status
Completed
Last Updated
5 years ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
August 10, 2019
End Date
August 30, 2020
Last Updated
5 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Post Graduate Institute of Medical Education and Research, Chandigarh
Responsible Party
Principal Investigator
Principal Investigator

Dr. Subhrashis Guha Niyogi

Fellow, Cardiac Anaesthesia

Post Graduate Institute of Medical Education and Research, Chandigarh

Eligibility Criteria

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.

Outcomes

Primary Outcomes

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

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

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.

Secondary Outcomes

  • 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.)

Study Sites (1)

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