Internal Jugular Vein Respiratory Variability as a Marker of Disease Severity in Infant Bronchiolitis
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age1-23
SponsorEskisehir Osmangazi University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial population
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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Point-of-Care Ultrasonography
Diagnostic testA 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.
Treatment groups
120 Participants
are divided into 1 treatment groupGroup A: Acute Bronchiolitis Cohort1 intervention
Trial outcomes
Primary outcomes
1
Correlation Between Internal Jugular Vein Respiratory Variability Index and Wang Bronchiolitis Severity Score
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.
Time frame
At enrollment (baseline, within 6 hours of emergency department presentation)Secondary outcomes
1
Correlation Between IJV Variability Index and Oxygen Saturation, Respiratory Rate, and Retraction Severity
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.
Time frame
At enrollment (baseline, within 6 hours of emergency department presentation)2
Association Between IJV Variability Index and Need for High-Flow Nasal Cannula or Supplemental Oxygen Therapy
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.
Time frame
From enrollment through hospital discharge, assessed up to approximately 7 days3
Association Between IJV Variability Index and Pediatric Intensive Care Unit Admission
Comparison of baseline IJV Variability Index between infants admitted and not admitted to the pediatric intensive care unit (PICU) during hospitalization.
Time frame
From enrollment through hospital discharge, assessed up to approximately 7 days4
Correlation Between Diaphragm Ultrasound Parameters and IJV Variability Index and Clinical Severity Scores
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.
Time frame
At enrollment (baseline, within 6 hours of emergency department presentation)Other outcomes
1
Discriminative Performance of a Multimodal Point-of-Care Ultrasound Model Versus Wang Bronchiolitis Severity Score for Predicting Escalated Respiratory Support
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.
Time frame
From enrollment through 24 hours after enrollmentSponsors and contacts
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Source ClinicalTrials.gov
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