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

2026년 8월 20일 업데이트: 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.

연구 개요

상태

아직 모집하지 않음

정황

개입 / 치료

상세 설명

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.

연구 유형

관찰

등록 (추정된)

120

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

연구 장소

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

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 어린이

건강한 자원 봉사자를 받아들입니다

아니

샘플링 방법

비확률 샘플

연구 인구

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.

설명

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

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

코호트 및 개입

그룹/코호트
개입 / 치료
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.
진단 검사: 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.
다른 이름들:
  • 초점

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Correlation Between Internal Jugular Vein Respiratory Variability Index and Wang Bronchiolitis Severity Score
기간: 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)

2차 결과 측정

결과 측정
측정값 설명
기간
Correlation Between IJV Variability Index and Oxygen Saturation, Respiratory Rate, and Retraction Severity
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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)

기타 결과 측정

결과 측정
측정값 설명
기간
Discriminative Performance of a Multimodal Point-of-Care Ultrasound Model Versus Wang Bronchiolitis Severity Score for Predicting Escalated Respiratory Support
기간: 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

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Eskisehir Osmangazi University

수사관

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

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

일반 간행물

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (추정된)

2026년 9월 1일

기본 완료 (추정된)

2027년 3월 31일

연구 완료 (추정된)

2027년 8월 31일

연구 등록 날짜

최초 제출

2026년 8월 15일

QC 기준을 충족하는 최초 제출

2026년 8월 20일

처음 게시됨 (실제)

2026년 8월 21일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 8월 21일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 8월 20일

마지막으로 확인됨

2026년 8월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • IJVBRONCH-2026-01

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

미정

IPD 계획 설명

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.

약물 및 장치 정보, 연구 문서

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아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

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