Clinical trial NCT04417790: Utility of Lung Ultrasound in the Estimation of Extravascular Lung Water in Pediatric Population
Official title: Utility of Lung Ultrasound in the Estimation of Extravascular Lung Water in Pediatric Population- a Prospective Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pulmonary Congestion
Congenital Heart Disease
Post-Op Complication
Keywords: Lung ultrasound
Transpulmonary thermodilution
Lead sponsor: PGIMER
Sponsor class: UNKNOWN
First posted: 2020-06-05
Enrollment: 25
Sex: ALL
Minimum age (years): 1
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children with cyanotic or acyanotic heart undergoing elective cardiac surgery.

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.


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.

Primary outcomes:
measure: correlation of lung USG B-line score with PICCO derived EVLW / EVLWI in pediatric cardiac surgical patients.
timeFrame: Till extubation or second post-operative day.
measure: cutoffs for lung USG B-line score to Predict abnormal EVLWI values.
timeFrame: Till extubation or second post-operative day.
Secondary outcomes:
measure: trending ability of lung USG B-line score to predict PICCO derived EVLW / EVLWI in pediatric cardiac surgical patients.
timeFrame: Till extubation or second post-operative day.
Other outcomes:
Locations:
city: Chandigarh
country: India
facility: Postgraduate Institute of Medical Education & Research
Study officials:
affiliation: Post Graduate Institute of Medical Education and Research, Chandigarh
name: Bhupesh Kumar, DM
role: STUDY_DIRECTOR
References: