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NCT Number: NCT07778225

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

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.

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Key information

Age range

1 month–23 month

Sex eligibility

All sexes

Study type

Observational

Primary location

Eskisehir Osmangazi University Faculty of Medicine, Pediatric Emergency Department

Eskişehir, 26480, Turkey (Türkiye)

Location contact

Emre Güngör, Medical Doctor

CONTACT

[email protected]

+90 222 239 2979 ext. 5214

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Point-of-Care Ultrasonography

Diagnostic Test

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.

Other names: POCUS

Primary outcomes

  1. Correlation Between Internal Jugular Vein Respiratory Variability Index and Wang Bronchiolitis Severity Score

    Time frame: 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.

Secondary outcomes

  1. Correlation Between IJV Variability Index and Oxygen Saturation, Respiratory Rate, and Retraction Severity

    Time frame: At 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.

  2. Association Between IJV Variability Index and Need for High-Flow Nasal Cannula or Supplemental Oxygen Therapy

    Time frame: From enrollment through hospital discharge, assessed up to approximately 7 days

    Comparison of baseline IJV Variability Index between infants who require and do not require high-flow nasal cannula (HFNC) or supplemental oxygen therapy during hospitalization.

  3. Association Between IJV Variability Index and Pediatric Intensive Care Unit Admission

    Time frame: From enrollment through hospital discharge, assessed up to approximately 7 days

    Comparison of baseline IJV Variability Index between infants admitted and not admitted to the pediatric intensive care unit (PICU) during hospitalization.

  4. Correlation Between Diaphragm Ultrasound Parameters and IJV Variability Index and Clinical Severity Scores

    Time frame: At 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.

  5. Correlation Between IJV Variability Index and Modified Tal Score

    Time frame: At 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.

  6. Correlation Between IJV Variability Index and Respiratory Distress Assessment Instrument

    Time frame: At 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.

  7. Association Between IJV Variability Index and Respiratory Assessment Change Score

    Time frame: Baseline and 2-4 hours after enrollment

    Association 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.

  8. Correlation Between IJV Variability Index and Kristjansson Respiratory Score

    Time frame: At 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.

Other outcomes

  1. Discriminative Performance of a Multimodal Point-of-Care Ultrasound Model Versus Wang Bronchiolitis Severity Score for Predicting Escalated Respiratory Support

    Time frame: From enrollment through 24 hours after enrollment

    Area under the receiver operating characteristic curve (AUC, 95% confidence interval) for a multimodal model combining baseline IJV Variability Index, lung ultrasound score, and diaphragm ultrasound parameters, compared with the Wang Bronchiolitis Severity Score alone using the DeLong test. The lung ultrasound score ranges from 0 to 36, with higher scores indicating greater pulmonary aeration abnormality. The Wang Bronchiolitis Severity Score ranges from 0 to 12, with higher scores indicating greater bronchiolitis severity.

Study contacts

Contact information is provided by the study sponsor or research team.

Emre Güngör, Medical Doctor

CONTACT

[email protected]

+90 222 239 2979 ext. 5214

Sponsors and collaborators

Lead sponsor

Eskisehir Osmangazi University

Other

Registry information

Official study title

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

Acronym: IJV-BRONCH

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Aug 21, 2026
Registry last updated
Aug 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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