NCT02004938

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 19, 2013

Completed
4 months until next milestone

First Posted

Study publicly available on registry

December 9, 2013

Completed
23 days until next milestone

Study Start

First participant enrolled

January 1, 2014

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2015

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
Last Updated

May 4, 2017

Status Verified

May 1, 2017

Enrollment Period

1 year

First QC Date

August 19, 2013

Last Update Submit

May 1, 2017

Conditions

Keywords

measurementsjugularultrasoundpediatricrespiratorydiameter

Outcome Measures

Primary Outcomes (1)

  • Measurement of diameter of right internal jugular vein during the respiratory cycle at max inhalation and exhalation

    During ED stay at initiation of intervention

Secondary Outcomes (2)

  • Clinical Asthma Score

    During ED stay at initiation of intervention

  • Measurement of level of dehydration

    During ED stay

Study Arms (1)

normal respiratory function

This will include the 40 subjects enrolled in the study

Device: Sonosite Titan Ultrasound Machine

Interventions

normal respiratory function

Eligibility Criteria

Age6 Years - 17 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

pediatric emergency department

You may qualify if:

  • Subjects ages 6-17 years old presenting to the emergency department (ED) will be enrolled into the normal respiratory function group.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kosair Children's Hospital

Louisville, Kentucky, 40202, United States

Location

Study Officials

  • Michelle D Stevenson, MD, MS

    University of Louisville

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

August 19, 2013

First Posted

December 9, 2013

Study Start

January 1, 2014

Primary Completion

January 1, 2015

Study Completion

June 1, 2015

Last Updated

May 4, 2017

Record last verified: 2017-05

Locations