An observational study in Ultrasound Measurements and Normative Values, sponsored by University of Louisville. Completed at 1 site in United States. Open to participants aged 6 Years to 17 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-05-04.
Sponsored by University of Louisville · Observational
Project Aims: The purpose of this study is to determine the size of the right internal jugular vein (RIJV) in children with normal respiratory physiology during the respiratory cycle and evaluate the reliability of those measurements.
Hypothesis: Ultrasound measurements of internal jugular vein collapse of children can be reliably measured in the respiratory cycle.
Intervention: We will ensure that the patient is not having any respiratory symptoms or signs of dehydration. A clinical asthma score will be assigned using the Modified Woods pulmonary index scoring system. The Gorelick Dehydration Scale with also be calculated.
Using bedside ultrasonography with the Sonosite Titan ultrasound machine, each measurement will be taken with the subject lying in bed with the head of the bed elevated at 45 degrees with the subject's head in the neutral position and then turned 45 degrees leftward. Measurements of the internal jugular vein at maximal inhalation and exhalation will be recorded. Reliability calculations will be assessed.
University of Louisville is the lead sponsor of 284 studies on the registry; 53 are open to participants now.
Of its 20 completed or terminated interventional studies of FDA-regulated products, 7 (35%) have results posted.
Counted across the registry records on this site, refreshed daily.
pediatric emergency department
Subjects ages 6-17 years old presenting to the emergency department (ED) will be enrolled into the normal respiratory function group.
Exclusion Criteria:
Children will be excluded from participation if they have: a baseline chronic lung disorder (including asthma), current respiratory illness, fever, Emergency Services Index (ESI) triage category of less than or equal to 2 (emergent acuity), chronic cough, dyspnea with exercise, wheezing, or a history of smoking by self and/or parent report.
Subjects will be excluded if they had prior cardiac/pulmonary disease or surgeries (other than asthma for the acute exacerbation group), significant musculoskeletal abnormalities (such as scoliosis) that might compromise baseline pulmonary function testing, a history of smoking tobacco or marijuana, and prematurity (birth at less than 37 weeks gestation. In addition, those with an allergy to ultrasound gel will be excluded from participation.
This will include the 40 subjects enrolled in the study
Device: Sonosite Titan Ultrasound Machine
Measurement of diameter of right internal jugular vein during the respiratory cycle at max inhalation and exhalation
Time frame: During ED stay at initiation of intervention
Clinical Asthma Score
Will be recorded using Modified Woods pulmonary index scoring system.
Time frame: During ED stay at initiation of intervention
Measurement of level of dehydration
Will measure using the Gorelick scale.
Time frame: During ED stay
This study is completed, as verified in May 2017. You cannot join it, but the record below documents what was studied.
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University of Louisville