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Starting soon Observational

Internal Jugular Vein Respiratory Variability as a Marker of Disease Severity in Infant Bronchiolitis

NCT07778225 · tracked via the Priya Life Science Turkey tracker
Phase
Observational
Started
2026-09-01
Last updated
2026-08-21

Condition(s) studied

Acute BronchiolitisViral BronchiolitisRespiratory Syncytial Virus Infections

Investigational drug(s) / intervention(s)

Point-of-Care Ultrasonography

Point-of-Care Ultrasonography: A standardized point-of-care ultrasonography assessment will be performed in addition to routine clinical evaluation. The protocol includes M-mode assessment of the right internal jugular vein (IJV) to measure maximal and minimal respiratory-cycle diameters and calculate the IJV Variability Index (\[IJVmax-IJVmin\]/IJVmax × 100). Concurrent lung ultrasonography and diaphragm ultrasonography, including diaphragm excursion and thickening fraction, will also be performed. Ultrasonographic assessments are performed for research measurements only and do not determine or modify clinical treatment decisions.

Study summary

This prospective observational cohort study evaluates whether respiratory-cycle variation in internal jugular vein (IJV) diameter, measured by point-of-care ultrasound, correlates with clinical disease severity in infants 1-23 months of age presenting with acute bronchiolitis. Using a standardized M-mode protocol, the IJV Variability Index (\[IJVmax-IJVmin\]/IJVmax x 100) will be calculated and compared with the Wang Bronchiolitis Severity Score, four additional validated clinical severity instruments (Modified Tal Score, Respiratory Distress Assessment Instrument, Kristjansson Respiratory Score, Respiratory Assessment Change Score), oxygen saturation, respiratory rate, need for high-flow nasal cannula or supplemental oxygen, pediatric intensive care unit admission, and length of hospital stay. Concurrent lung and diaphragm point-of-care ultrasound will be performed to build a multimodal ultrasound severity model. No intervention is assigned; all ultrasound assessments are performed in addition to standard clinical care and do not alter treatment decisions.

Eligibility

Sex
ALL
Min age
1 Month
Max age
23 Months
Healthy volunteers
No
Inclusion Criteria: * Infants aged 1-23 months * Clinical diagnosis of acute bronchiolitis per AAP (2014) criteria (first wheezing episode following an upper respiratory infection prodrome, with tachypnea, retractions, and/or crackles) * Written informed consent obtained from parent/legal guardian * Evaluable within the first 6 hours of emergency department presentation Exclusion Criteria: * Underlying congenital heart disease * Chronic lung disease (bronchopulmonary dysplasia, cystic fibrosis) * Prior history of recurrent wheezing/suspected asthma * Anatomical abnormality of the neck or prior history of central venous catheterization or jugular vein thrombosis * Hemodynamic instability/shock * Immediate need for intubation/mechanical ventilation precluding ultrasound assessment * Parent/legal guardian declines consent

Primary outcome measure(s)

  • Correlation Between Internal Jugular Vein Respiratory Variability Index and Wang Bronchiolitis Severity Score — At enrollment (baseline, within 6 hours of emergency department presentation)
    Correlation between the Internal Jugular Vein (IJV) Variability Index and the Wang Bronchiolitis Severity Score. The IJV Variability Index will be calculated as (\[IJVmax - IJVmin\] / IJVmax) × 100, where IJVmax and IJVmin represent the maximum and minimum IJV diameters measured during the respiratory cycle. The Wang Bronchiolitis Severity Score ranges from 0 to 12, with higher scores indicating greater disease severity. The association will be quantified using Pearson or Spearman correlation coefficients, as appropriate.

Trial sites (1)

FacilityCityRegionStatus
Eskisehir Osmangazi University Faculty of Medicine, Pediatric Emergency Department Eskişehir Eskişehir
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07778225 on ClinicalTrials.gov ↗ ← All trials in Turkey