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

20. srpna 2026 aktualizováno: 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.

Přehled studie

Postavení

Zatím nenabíráme

Podmínky

Intervence / Léčba

Detailní popis

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.

Typ studie

Pozorovací

Zápis (Odhadovaný)

120

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní kontakt

  • Jméno: Emre Güngör, Medical Doctor
  • Telefonní číslo: 5214 +90 222 239 2979
  • E-mail: emre.gungor@ogu.edu.tr

Studijní místa

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

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

  • Dítě

Přijímá zdravé dobrovolníky

Ne

Metoda odběru vzorků

Vzorek nepravděpodobnosti

Studijní populace

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.

Popis

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

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

Kohorty a intervence

Skupina / kohorta
Intervence / Léčba
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.
Diagnostický test: 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.
Ostatní jména:
  • POCUS

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Correlation Between Internal Jugular Vein Respiratory Variability Index and Wang Bronchiolitis Severity Score
Časové okno: 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)

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Correlation Between IJV Variability Index and Oxygen Saturation, Respiratory Rate, and Retraction Severity
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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)

Další výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Discriminative Performance of a Multimodal Point-of-Care Ultrasound Model Versus Wang Bronchiolitis Severity Score for Predicting Escalated Respiratory Support
Časové okno: 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

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

Eskisehir Osmangazi University

Vyšetřovatelé

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

Publikace a užitečné odkazy

Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.

Obecné publikace

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Odhadovaný)

1. září 2026

Primární dokončení (Odhadovaný)

31. března 2027

Dokončení studie (Odhadovaný)

31. srpna 2027

Termíny zápisu do studia

První předloženo

15. srpna 2026

První předloženo, které splnilo kritéria kontroly kvality

20. srpna 2026

První zveřejněno (Aktuální)

21. srpna 2026

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

21. srpna 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

20. srpna 2026

Naposledy ověřeno

1. srpna 2026

Více informací

Termíny související s touto studií

Klíčová slova

Další relevantní podmínky MeSH

Další identifikační čísla studie

  • IJVBRONCH-2026-01

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

NEROZHODNÝ

Popis plánu 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.

Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

Ne

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

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