Internal Jugular Vein Respiratory Variability as a Marker of Disease Severity in Infant Bronchiolitis (IJV-BRONCH)
2026年8月20日 更新者：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.
調査の概要
詳細な説明
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.
研究の種類
観察的
入学 (推定)
120
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
- 名前：Emre Güngör, Medical Doctor
- 電話番号：5214 +90 222 239 2979
- メール：emre.gungor@ogu.edu.tr
研究場所
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Eskişehir
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Eskişehir、Eskişehir、トルコ（Türkiye）、26480
- Eskisehir Osmangazi University Faculty of Medicine, Pediatric Emergency Department
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コンタクト：
- Emre Güngör, Medical Doctor
- 電話番号：5214 +90 222 239 2979
- メール：emre.gungor@ogu.edu.tr
-
-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 子
健康ボランティアの受け入れ
いいえ
サンプリング方法
非確率サンプル
調査対象母集団
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.
説明
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
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
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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.
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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.
他の名前：
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Correlation Between Internal Jugular Vein Respiratory Variability Index and Wang Bronchiolitis Severity Score
時間枠：At enrollment (baseline, within 6 hours of emergency department presentation)
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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.
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At enrollment (baseline, within 6 hours of emergency department presentation)
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Correlation Between IJV Variability Index and Oxygen Saturation, Respiratory Rate, and Retraction Severity
時間枠：At enrollment (baseline, within 6 hours of emergency department presentation)
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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.
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At enrollment (baseline, within 6 hours of emergency department presentation)
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Association Between IJV Variability Index and Need for High-Flow Nasal Cannula or Supplemental Oxygen Therapy
時間枠：From enrollment through hospital discharge, assessed up to approximately 7 days
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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.
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From enrollment through hospital discharge, assessed up to approximately 7 days
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Association Between IJV Variability Index and Pediatric Intensive Care Unit Admission
時間枠：From enrollment through hospital discharge, assessed up to approximately 7 days
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Comparison of baseline IJV Variability Index between infants admitted and not admitted to the pediatric intensive care unit (PICU) during hospitalization.
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From enrollment through hospital discharge, assessed up to approximately 7 days
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Correlation Between Diaphragm Ultrasound Parameters and IJV Variability Index and Clinical Severity Scores
時間枠：At enrollment (baseline, within 6 hours of emergency department presentation)
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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.
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At enrollment (baseline, within 6 hours of emergency department presentation)
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Correlation Between IJV Variability Index and Modified Tal Score
時間枠：At enrollment (baseline, within 6 hours of emergency department presentation)
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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.
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At enrollment (baseline, within 6 hours of emergency department presentation)
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Correlation Between IJV Variability Index and Respiratory Distress Assessment Instrument
時間枠：At enrollment (baseline, within 6 hours of emergency department presentation)
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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.
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At enrollment (baseline, within 6 hours of emergency department presentation)
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Association Between IJV Variability Index and Respiratory Assessment Change Score
時間枠：Baseline and 2-4 hours after enrollment
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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.
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Baseline and 2-4 hours after enrollment
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Correlation Between IJV Variability Index and Kristjansson Respiratory Score
時間枠：At enrollment (baseline, within 6 hours of emergency department presentation)
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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.
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At enrollment (baseline, within 6 hours of emergency department presentation)
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その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Discriminative Performance of a Multimodal Point-of-Care Ultrasound Model Versus Wang Bronchiolitis Severity Score for Predicting Escalated Respiratory Support
時間枠：From enrollment through 24 hours after enrollment
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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.
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From enrollment through 24 hours after enrollment
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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
捜査官
- 主任研究者：Emre Güngör, Medical Doctor、Eskisehir Osmangazi University Faculty of Medicine, Department of Pediatrics, Division of Pediatric Emergency Medicine
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
一般刊行物
- McCallum GB, Morris PS, Wilson CC, Versteegh LA, Ward LM, Chatfield MD, Chang AB. Severity scoring systems: are they internally valid, reliable and predictive of oxygen use in children with acute bronchiolitis? Pediatr Pulmonol. 2013 Aug;48(8):797-803. doi: 10.1002/ppul.22627. Epub 2012 Sep 4.
- Ralston SL, Lieberthal AS, Meissner HC, Alverson BK, Baley JE, Gadomski AM, Johnson DW, Light MJ, Maraqa NF, Mendonca EA, Phelan KJ, Zorc JJ, Stanko-Lopp D, Brown MA, Nathanson I, Rosenblum E, Sayles S 3rd, Hernandez-Cancio S; American Academy of Pediatrics. Clinical practice guideline: the diagnosis, management, and prevention of bronchiolitis. Pediatrics. 2014 Nov;134(5):e1474-502. doi: 10.1542/peds.2014-2742.
- Right Internal Jugular Ultrasound Measurements during the Respiratory Cycle in Children Journal Authors: AM IsacoffDJ McLarioKP CrossAR O'HaganBJ HollandDJ LorenzMD Stevenson DOI: 10.7727/wimj.2016.540 ABSTRACT Background: Point of care ultrasound could be useful as a non-invasive objective measure of throughout the respiratory cycle. Objective: To determine the reliability of measurements of the right internal jugular vein (RIJV). Methods: We performed a prospective observation study of children aged 6-17 years. Using M-mode ultrasonography one centimeter cephalad from the clavicle, triplicate measurements were recorded during inhalation and exhalation with the head straight ahead and 45 degrees leftward. Results: Among the 40 enrolled subjects, mean diameters ± standard deviations of the RIJV (cm) were: maximum inhalation with head straight ahead (0.53 ± 0.18), leftward (0.78 ± 0.22); maximum exhalation with head straight ahead (0.54 ± 0.19), leftward (0.79 ± 0.22). Intraclass correlation coefficients were all significant (p<0.001). Conclusion: The RIJV diameter can be reliably measured during the respiratory cycle; measures are larger with head turned 45 degrees leftward. Received: 28 Oct, 2016 Accepted: 03 Jan, 2017
- Giorno EPC, Foronda FK, De Paulis M, Bou Ghosn DSN, Couto TB, Sa FVM, Fraga AMA, Farhat SCL, Preto-Zamperlini M, Schvartsman C. Point-of-care lung ultrasound score for predicting escalated care in children with respiratory distress. Am J Emerg Med. 2023 Jun;68:112-118. doi: 10.1016/j.ajem.2023.02.035. Epub 2023 Mar 1.
- Bilgili B, Haliloglu M, Tugtepe H, Umuroglu T. The Assessment of Intravascular Volume with Inferior Vena Cava and Internal Jugular Vein Distensibility Indexes in Children Undergoing Urologic Surgery. J Invest Surg. 2018 Dec;31(6):523-528. doi: 10.1080/08941939.2017.1364806. Epub 2017 Sep 27.
- Jayasimha K, Liu W, Hanna W. Use of Internal Jugular Vein POCUS to Assess Intravascular Volume Status: A Study in Critically Ill Pediatric Post-Operative Cardiac Patients. POCUS J. 2025 Nov 17;10(2):109-114. doi: 10.24908/pocusj.v10i02.18249. eCollection 2025 Nov.
- Fernandes RM, Plint AC, Terwee CB, Sampaio C, Klassen TP, Offringa M, van der Lee JH. Validity of bronchiolitis outcome measures. Pediatrics. 2015 Jun;135(6):e1399-408. doi: 10.1542/peds.2014-3557. Epub 2015 May 18.
- Sik N, Citlenbik H, Ozturk A, Yilmaz D, Duman M. Point of care diaphragm ultrasound in acute bronchiolitis: A measurable tool to predict the clinical, sonographic severity of the disease, and outcomes. Pediatr Pulmonol. 2021 May;56(5):1053-1059. doi: 10.1002/ppul.25268. Epub 2021 Jan 26.
- Curinha F, Fernandes A, Pinto C, Dionisio MT. Thoracic Ultrasound in Pediatric Intensive Care: A Valuable Tool for Children with Acute Bronchiolitis. Acta Med Port. 2026 Apr 1;39(4):271-280. doi: 10.20344/amp.24309. Epub 2026 Apr 1.
- Drum B, La Course B, Kelly M, York A, Worrall E, Martins J, Johnson S, Liles EA Jr. Does This Patient Have Volume Overload?: The Rational Clinical Examination. JAMA. 2026 Apr 7;335(13):1159-1168. doi: 10.1001/jama.2026.0446.
- Wang EE, Milner R, Allen U, Maj H. Bronchodilators for treatment of mild bronchiolitis: a factorial randomised trial. Arch Dis Child. 1992 Mar;67(3):289-93. doi: 10.1136/adc.67.3.289.
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (推定)
2026年9月1日
一次修了 (推定)
2027年3月31日
研究の完了 (推定)
2027年8月31日
試験登録日
最初に提出
2026年8月15日
QC基準を満たした最初の提出物
2026年8月20日
最初の投稿 (実際)
2026年8月21日
学習記録の更新
投稿された最後の更新 (実際)
2026年8月21日
QC基準を満たした最後の更新が送信されました
2026年8月20日
最終確認日
2026年8月1日
詳しくは
本研究に関する用語
キーワード
追加の関連 MeSH 用語
その他の研究ID番号
- IJVBRONCH-2026-01
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
未定
IPD プランの説明
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.
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