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Internal Jugular Vein Respiratory Variability as a Marker of Disease Severity in Infant Bronchiolitis (IJV-BRONCH)

20 de agosto de 2026 atualizado por: Emre Güngör, Eskisehir Osmangazi University

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

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.

Visão geral do estudo

Status

Ainda não está recrutando

Condições

Intervenção / Tratamento

Descrição detalhada

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.

Tipo de estudo

Observacional

Inscrição (Estimado)

120

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Contato de estudo

  • Nome: Emre Güngör, Medical Doctor
  • Número de telefone: 5214 +90 222 239 2979
  • E-mail: emre.gungor@ogu.edu.tr

Locais de estudo

  • Turquia (Türkiye)
    • Eskişehir
      • Eskişehir, Eskişehir, Turquia (Türkiye), 26480
        • Eskisehir Osmangazi University Faculty of Medicine, Pediatric Emergency Department
        • Contato:

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

  • Filho

Aceita Voluntários Saudáveis

Não

Método de amostragem

Amostra Não Probabilística

População do estudo

Infants aged 1 to 23 months presenting to the Pediatric Emergency Department with a clinical diagnosis of acute bronchiolitis according to the American Academy of Pediatrics (AAP) clinical criteria will be prospectively enrolled. Eligible participants will be evaluated within the first 6 hours of emergency department presentation after written informed consent is obtained from a parent or legal guardian. Participants will undergo standardized clinical severity assessment and point-of-care ultrasonography of the internal jugular vein, lungs, and diaphragm in addition to routine clinical care. No study-specific therapeutic intervention will be assigned.

Descrição

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

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

Coortes e Intervenções

Grupo / Coorte
Intervenção / Tratamento
Acute Bronchiolitis Cohort
Infants aged 1-23 months diagnosed with acute bronchiolitis per AAP (2014) clinical practice guideline criteria, undergoing a standardized point-of-care ultrasound assessment (internal jugular vein, lung, and diaphragm) in addition to standard clinical evaluation and treatment. No intervention is assigned as part of this study; the cohort will be stratified post hoc by clinical severity scores for descriptive and exploratory subgroup analyses.
Teste de diagnostico: 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.
Outros nomes:
  • POCUS

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Correlation Between Internal Jugular Vein Respiratory Variability Index and Wang Bronchiolitis Severity Score
Prazo: 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.
At enrollment (baseline, within 6 hours of emergency department presentation)

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Correlation Between IJV Variability Index and Oxygen Saturation, Respiratory Rate, and Retraction Severity
Prazo: 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.
At enrollment (baseline, within 6 hours of emergency department presentation)
Association Between IJV Variability Index and Need for High-Flow Nasal Cannula or Supplemental Oxygen Therapy
Prazo: 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.
From enrollment through hospital discharge, assessed up to approximately 7 days
Association Between IJV Variability Index and Pediatric Intensive Care Unit Admission
Prazo: 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.
From enrollment through hospital discharge, assessed up to approximately 7 days
Correlation Between Diaphragm Ultrasound Parameters and IJV Variability Index and Clinical Severity Scores
Prazo: 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.
At enrollment (baseline, within 6 hours of emergency department presentation)
Correlation Between IJV Variability Index and Modified Tal Score
Prazo: 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.
At enrollment (baseline, within 6 hours of emergency department presentation)
Correlation Between IJV Variability Index and Respiratory Distress Assessment Instrument
Prazo: 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.
At enrollment (baseline, within 6 hours of emergency department presentation)
Association Between IJV Variability Index and Respiratory Assessment Change Score
Prazo: 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.
Baseline and 2-4 hours after enrollment
Correlation Between IJV Variability Index and Kristjansson Respiratory Score
Prazo: 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.
At enrollment (baseline, within 6 hours of emergency department presentation)

Outras medidas de resultado

Medida de resultado
Descrição da medida
Prazo
Discriminative Performance of a Multimodal Point-of-Care Ultrasound Model Versus Wang Bronchiolitis Severity Score for Predicting Escalated Respiratory Support
Prazo: 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.
From enrollment through 24 hours after enrollment

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Eskisehir Osmangazi University

Investigadores

  • Investigador principal: Emre Güngör, Medical Doctor, Eskisehir Osmangazi University Faculty of Medicine, Department of Pediatrics, Division of Pediatric Emergency Medicine

Publicações e links úteis

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Publicações Gerais

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Estimado)

1 de setembro de 2026

Conclusão Primária (Estimado)

31 de março de 2027

Conclusão do estudo (Estimado)

31 de agosto de 2027

Datas de inscrição no estudo

Enviado pela primeira vez

15 de agosto de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

20 de agosto de 2026

Primeira postagem (Real)

21 de agosto de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

21 de agosto de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

20 de agosto de 2026

Última verificação

1 de agosto de 2026

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • IJVBRONCH-2026-01

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

INDECISO

Descrição do plano IPD

The plan for sharing de-identified individual participant data has not yet been finalized. A data-sharing decision will be made before publication, taking into account participant confidentiality, ethics committee requirements, institutional policies, and applicable data protection regulations.

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

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