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Completed

NCT Number: NCT02004938

Internal Jugular Ultrasound Measures During Respiration in Children

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.

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Key information

Conditions

Ultrasound Measurements Normative Values

Age range

6 year–17 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Kosair Children's Hospital

Louisville, Kentucky, 40202, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Sonosite Titan Ultrasound Machine

Device

Primary outcomes

  1. 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

Secondary outcomes

  1. Clinical Asthma Score

    Time frame: During ED stay at initiation of intervention

    Will be recorded using Modified Woods pulmonary index scoring system.

  2. Measurement of level of dehydration

    Time frame: During ED stay

    Will measure using the Gorelick scale.

Sponsors and collaborators

Lead sponsor

University of Louisville

Other

Registry information

Official study title

Characteristics of the Internal Jugular Vein by Ultrasonography During Respiration in Children

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Dec 9, 2013
Registry last updated
May 4, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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