Clinical trial NCT02004938: Internal Jugular Ultrasound Measures During Respiration in Children
Official title: Characteristics of the Internal Jugular Vein by Ultrasonography During Respiration in Children
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ultrasound Measurements
Normative Values
Keywords: measurements
jugular
ultrasound
pediatric
respiratory
diameter
Lead sponsor: University of Louisville
Sponsor class: OTHER
First posted: 2013-12-09
Enrollment: 40
Sex: ALL
Minimum age (years): 6
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: pediatric emergency department

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

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.

Primary outcomes:
measure: Measurement of diameter of right internal jugular vein during the respiratory cycle at max inhalation and exhalation
timeFrame: During ED stay at initiation of intervention
Secondary outcomes:
measure: Clinical Asthma Score
timeFrame: During ED stay at initiation of intervention
measure: Measurement of level of dehydration
timeFrame: During ED stay
Other outcomes:
Locations:
city: Louisville
country: United States
facility: Kosair Children's Hospital
state: Kentucky
Study officials:
affiliation: University of Louisville
name: Michelle D Stevenson, MD, MS
role: PRINCIPAL_INVESTIGATOR
References: