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

NCT04417790 | Completed

• 1 other identifier: INT/IEC/2019/001513
• Study Type: observational
• Target: 25
• Locations: 1 country
• Sites: 1

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

Keywords

Lung ultrasound; Transpulmonary thermodilution

Outcome Measures

Primary Outcomes (2)

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

  Till extubation or second post-operative day.

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

  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.

  Till extubation or second post-operative day.

Study Arms (1)

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.

Diagnostic Test: Lung ultrasound and EVLW measurement by transpulmonary thermodilution.

Interventions

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

Study population

Eligibility Criteria

• Age: 1 Year - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Children with cyanotic or acyanotic heart undergoing elective cardiac surgery.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Post Graduate Institute of Medical Education and Research, Chandigarh: lead

Study Sites (1)

Postgraduate Institute of Medical Education & Research

Chandigarh, 160012, India

Location

MeSH Terms

Conditions

Heart Defects, Congenital; Postoperative Complications

Condition Hierarchy (Ancestors)

Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Bhupesh Kumar, DM

  Post Graduate Institute of Medical Education and Research, Chandigarh

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Fellow, Cardiac Anaesthesia

Study Record Dates

• First Submitted: June 2, 2020
• First Posted: June 5, 2020
• Study Start: August 10, 2019
• Primary Completion: August 15, 2020
• Study Completion: August 30, 2020
• Last Updated: September 14, 2020

Record last verified: 2020-09

Locations

IN (1)