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

Respiratory Variation of Internal Jugular Vein Diameter as a Novel Ultrasonographic Marker of Disease Severity in Infants With Acute Bronchiolitis: A Prospective Observational Cohort Study

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07778225
Acronym
IJV-BRONCH
Enrollment
120
Registered
2026-08-21
Start date
2026-09-01
Completion date
2027-08-31
Last updated
2026-08-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Bronchiolitis, Respiratory Syncytial Virus Infections, Viral Bronchiolitis

Keywords

bronchiolitis, point-of-care ultrasound, internal jugular vein, lung ultrasound, pediatric emergency medicine

Brief 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.

Detailed description

Bronchiolitis is among the leading causes of hospitalization in infants under 2 years of age. Existing clinical severity scores show limited inter-observer agreement and weak correlation with oxygenation. Point-of-care ultrasound (lung ultrasound, diaphragm ultrasound) has been studied as an adjunct severity marker in bronchiolitis. Still, respiratory-cycle variability of the internal jugular vein (IJV) diameter has not previously been investigated in this population. A prior reliability study in healthy children demonstrated that right internal jugular vein (RIJV) diameter can be reliably measured by M-mode ultrasound and does not vary significantly across the respiratory cycle in the absence of respiratory distress; the study authors explicitly proposed that RIJV diameter and its respiratory variation be investigated as a surrogate marker of pulmonary function in children with respiratory distress. This study extends that proposed application to infants with acute bronchiolitis. Eligible infants aged 1-23 months meeting AAP (2014) clinical criteria for acute bronchiolitis will undergo a standardized ultrasound protocol (45-degree head elevation, linear probe, right internal jugular vein imaged approximately 1 cm cephalad to the sternoclavicular junction, B-mode identification followed by M-mode measurement of maximal inspiratory and expiratory diameters) performed by a blinded, trained sonographer. We will record concurrent clinical severity scoring, lung ultrasound, and diaphragm ultrasound (excursion, thickening fraction). The primary analysis will test the correlation between the IJV Variability Index and the Wang Bronchiolitis Severity Score; secondary analyses will examine correlations with additional validated severity scores, physiologic parameters, and clinical outcomes (respiratory support escalation, length of stay), as well as inter-/intra-observer reliability and the discriminative performance of a multimodal point-of-care ultrasound model.

Interventions

DIAGNOSTIC_TESTPoint-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.

Sponsors

Eskisehir Osmangazi University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
1 Months to 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

Design outcomes

Primary

MeasureTime frameDescription
Correlation Between Internal Jugular Vein Respiratory Variability Index and Wang Bronchiolitis Severity ScoreAt 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.

Secondary

MeasureTime frameDescription
Correlation Between IJV Variability Index and Oxygen Saturation, Respiratory Rate, and Retraction SeverityAt enrollment (baseline, within 6 hours of emergency department presentation)Correlation between the IJV Variability Index and oxygen saturation (SpO2, %), respiratory rate (breaths/minute), and the retraction component of the Wang Bronchiolitis Severity Score. The retraction component ranges from 0 to 3, with higher scores indicating more severe retractions.
Association Between IJV Variability Index and Need for High-Flow Nasal Cannula or Supplemental Oxygen TherapyFrom enrollment through hospital discharge, assessed up to approximately 7 daysComparison of baseline IJV Variability Index between infants who require and do not require high-flow nasal cannula (HFNC) or supplemental oxygen therapy during hospitalization.
Association Between IJV Variability Index and Pediatric Intensive Care Unit AdmissionFrom enrollment through hospital discharge, assessed up to approximately 7 daysComparison of baseline IJV Variability Index between infants admitted and not admitted to the pediatric intensive care unit (PICU) during hospitalization.
Correlation Between Diaphragm Ultrasound Parameters and IJV Variability Index and Clinical Severity ScoresAt enrollment (baseline, within 6 hours of emergency department presentation)Correlation of diaphragm excursion, diaphragm thickening fraction, and inspiratory/expiratory ratio with the IJV Variability Index and clinical severity scores. Clinical severity measures will include the Wang Bronchiolitis Severity Score (range 0-12), Modified Tal Score (range 0-12), Respiratory Distress Assessment Instrument (range 0-17), and Kristjansson Respiratory Score (range 0-10). For all four clinical severity scores, higher scores indicate greater disease or respiratory distress severity.
Correlation Between IJV Variability Index and Modified Tal ScoreAt enrollment (baseline, within 6 hours of emergency department presentation)Correlation between the IJV Variability Index and the Modified Tal Score. The Modified Tal Score ranges from 0 to 12, with higher scores indicating greater bronchiolitis severity.
Correlation Between IJV Variability Index and Respiratory Distress Assessment InstrumentAt enrollment (baseline, within 6 hours of emergency department presentation)Correlation between the IJV Variability Index and the Respiratory Distress Assessment Instrument (RDAI). The RDAI assesses wheezing and retractions and ranges from 0 to 17, with higher scores indicating greater respiratory distress.
Association Between IJV Variability Index and Respiratory Assessment Change ScoreBaseline and 2-4 hours after enrollmentAssociation between the baseline IJV Variability Index and the Respiratory Assessment Change Score (RACS). RACS quantifies change in respiratory status using the change in the Respiratory Distress Assessment Instrument together with a standardized change in respiratory rate between baseline and follow-up assessment. RACS is a change measure rather than a bounded scale and therefore does not have a fixed theoretical minimum or maximum.
Correlation Between IJV Variability Index and Kristjansson Respiratory ScoreAt enrollment (baseline, within 6 hours of emergency department presentation)Correlation between the IJV Variability Index and the Kristjansson Respiratory Score. The Kristjansson Respiratory Score ranges from 0 to 10, with higher scores indicating greater respiratory disease severity.

Countries

Turkey (Türkiye)

Contacts

CONTACTEmre Güngör, Medical Doctor
emre.gungor@ogu.edu.tr+90 222 239 2979
PRINCIPAL_INVESTIGATOREmre Güngör, Medical Doctor

Eskisehir Osmangazi University Faculty of Medicine, Department of Pediatrics, Division of Pediatric Emergency Medicine

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 22, 2026