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

Completed

• Conditions: Pulmonary Congestion; Congenital Heart Disease; Post-Op Complication
• Interventions: Diagnostic Test: Lung ultrasound and EVLW measurement by transpulmonary thermodilution.

• Registration Number: NCT04417790
• Lead Sponsor: Post Graduate Institute of Medical Education and Research, Chandigarh

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-08-10
• Study First Submitted: 2020-06-02
• Study First Submitted QC: 2020-06-02
• Study First Posted: 2020-06-05
• Primary Completion: 2020-08-15
• Study Completion: 2020-08-30
• Status Verified: 2020-09
• Last Update Submitted: 2020-09-11
• Last Update Posted: 2020-09-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Study population	Lung ultrasound and EVLW measurement by transpulmonary thermodilution.	Children under 12 years of age, Undergoing elective cardiac surgery for cyanotic or acyanotic congenital heart disease, Aristotle score ≤9, Giving prior written informed consent.

Primary Outcome Measures

Name	Time	Method
cutoffs for lung USG B-line score to Predict abnormal EVLWI values.	Till extubation or second post-operative day.
correlation of lung USG B-line score with PICCO derived EVLW / EVLWI in pediatric cardiac surgical patients.	Till extubation or second post-operative day.

Secondary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Postgraduate Institute of Medical Education & Research; 🇮🇳 Chandigarh, India