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Internal Jugular Ultrasound Measures During Respiration in Children

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ClinicalTrials.gov Identifier: NCT02004938
Recruitment Status : Completed
First Posted : December 9, 2013
Last Update Posted : May 4, 2017
Information provided by (Responsible Party):
Michelle D. Stevenson, University of Louisville

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.

Condition or disease Intervention/treatment
Ultrasound Measurements Normative Values Device: Sonosite Titan Ultrasound Machine

Study Type : Observational
Actual Enrollment : 40 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Characteristics of the Internal Jugular Vein by Ultrasonography During Respiration in Children
Study Start Date : January 2014
Primary Completion Date : January 2015
Study Completion Date : June 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ultrasound
U.S. FDA Resources

Group/Cohort Intervention/treatment
normal respiratory function
This will include the 40 subjects enrolled in the study
Device: Sonosite Titan Ultrasound Machine

Primary Outcome Measures :
  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 Outcome Measures :
  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.

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
pediatric emergency department

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02004938

United States, Kentucky
Kosair Children's Hospital
Louisville, Kentucky, United States, 40202
Sponsors and Collaborators
University of Louisville
Principal Investigator: Michelle D Stevenson, MD, MS University of Louisville

Responsible Party: Michelle D. Stevenson, Professor, University of Louisville
ClinicalTrials.gov Identifier: NCT02004938     History of Changes
Other Study ID Numbers: IRB 13.0345
First Posted: December 9, 2013    Key Record Dates
Last Update Posted: May 4, 2017
Last Verified: May 2017

Keywords provided by Michelle D. Stevenson, University of Louisville: