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

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

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.

Study Overview

• Status: Completed
• Conditions: Congenital Heart Disease; Post-Op Complication; Pulmonary Congestion
• Intervention / Treatment: Diagnostic test: Lung ultrasound and EVLW measurement by transpulmonary thermodilution.

• Study Type: Observational
• Enrollment (Actual): 25

Contacts and Locations

Study Locations

• India
  • Chandigarh, India, 160012
    • Postgraduate Institute of Medical Education & Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 12 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Children with cyanotic or acyanotic heart undergoing elective cardiac surgery.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.; Lung ultrasonography by 8 Quadrant protocol of Volpicelli et al. Transpulmonary thermodilution for extravascular lung water measurement

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
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.

Collaborators and Investigators

• Sponsor: Postgraduate Institute of Medical Education and Research
• Investigators: Study Director: Bhupesh Kumar, DM, Postgraduate Institute of Medical Education and Research

Study record dates

Study Major Dates

• Study Start (Actual): August 10, 2019
• Primary Completion (Actual): August 15, 2020
• Study Completion (Actual): August 30, 2020

Study Registration Dates

• First Submitted: June 2, 2020
• First Submitted That Met QC Criteria: June 2, 2020
• First Posted (Actual): June 5, 2020

Study Record Updates

• Last Update Posted (Actual): September 14, 2020
• Last Update Submitted That Met QC Criteria: September 11, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Keywords: Lung ultrasound; Transpulmonary thermodilution
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Congenital Abnormalities; Cardiovascular Abnormalities; Heart Diseases; Postoperative Complications; Heart Defects, Congenital
• Other Study ID Numbers: INT/IEC/2019/001513

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No