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

NCT ID: NCT04417790

Last Updated: 2020-09-14

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 25 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-08-10
• Study Completion Date: 2020-08-30

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.

Conditions

Pulmonary Congestion; Congenital Heart Disease; Post-Op Complication

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Study population

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.

Lung ultrasound and EVLW measurement by transpulmonary thermodilution.

Intervention Type: DIAGNOSTIC_TEST

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

Interventions

Lung ultrasound and EVLW measurement by transpulmonary thermodilution.

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

Intervention Type: DIAGNOSTIC_TEST

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.

• Minimum Eligible Age: 1 Year
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Post Graduate Institute of Medical Education and Research, Chandigarh

OTHER

Sponsor Role: lead

Responsible Party

Dr. Subhrashis Guha Niyogi

Fellow, Cardiac Anaesthesia

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Bhupesh Kumar, DM

Role: STUDY_DIRECTOR

Post Graduate Institute of Medical Education and Research, Chandigarh

Locations

Postgraduate Institute of Medical Education & Research

Chandigarh, , India

Countries

India

Other Identifiers

INT/IEC/2019/001513

Identifier Type: -

Identifier Source: org_study_id