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

Congenital Heart Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04417790
• Other study ID #: INT/IEC/2019/001513
• Status: Completed
• Start date: August 10, 2019
• Est. completion date: August 30, 2020

Study information

• Verified date: September 2020
• Source: Postgraduate Institute of Medical Education and Research
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: August 30, 2020
• Est. primary completion date: August 15, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 12 Years

Eligibility

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.

Related Conditions & MeSH terms

• Congenital Heart Disease
• Heart Diseases
• Post-Op Complication
• Postoperative Complications
• Pulmonary Congestion

Intervention

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

Locations

Country	Name	City	State
India	Postgraduate Institute of Medical Education & Research	Chandigarh

Sponsors (1)

Lead Sponsor	Collaborator
Postgraduate Institute of Medical Education and Research

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	correlation of lung USG B-line score with PICCO derived EVLW / EVLWI in pediatric cardiac surgical patients.		Till extubation or second post-operative day.
Primary	cutoffs for lung USG B-line score to Predict abnormal EVLWI values.		Till extubation or second post-operative day.
Secondary	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.