- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02004938
Internal Jugular Ultrasound Measures During Respiration in Children
Characteristics of the Internal Jugular Vein by Ultrasonography 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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Kentucky
-
Louisville, Kentucky, United States, 40202
- Kosair Children's Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
normal respiratory function
This will include the 40 subjects enrolled in the study
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
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
|
During ED stay at initiation of intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Clinical Asthma Score
Time Frame: During ED stay at initiation of intervention
|
Will be recorded using Modified Woods pulmonary index scoring system.
|
During ED stay at initiation of intervention
|
|
Measurement of level of dehydration
Time Frame: During ED stay
|
Will measure using the Gorelick scale.
|
During ED stay
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- IRB 13.0345
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Ultrasound Measurements
-
Rambam Health Care CampusUnknownComparison Between Ultrasound and Clinical MeasurementsIsrael
-
Meir Medical CenterUnknownMaternal Vitamin D Status | Neonatal Bone Quantitative Ultrasound MeasurementsIsrael
-
Hospices Civils de LyonCompletedObstetric Ultrasound Biometric Measurements With or Without IAFrance
-
Pennington Biomedical Research CenterTanitaCompletedBody Composition | Circumference Measurements | Tissue Thickness MeasurementsUnited States
-
Pennington Biomedical Research CenterSamsungCompletedBody Composition | Circumference Measurements | Tissue Thickness MeasurementsUnited States
-
Czech Technical University in PragueCompletedMovement Artifacts During SpO2 Measurements | Reduced Perfusion During SpO2 MeasurementsCzechia
-
King Saud UniversityCompletedGlycaemic Response MeasurementsSaudi Arabia
-
Mondelēz International, Inc.Reading Scientific Services Ltd.Completed
-
Northern State Medical UniversityCompletedCardiosurgery | Continuous Lactate MeasurementsRussian Federation
-
Sheffield Children's NHS Foundation TrustSheffield Hallam UniversityCompleted
Clinical Trials on Sonosite Titan Ultrasound Machine
-
Edward Via Virginia College of Osteopathic MedicineVirginia Polytechnic Institute and State UniversityCompletedHepatitis | Cholecystitis | Ascites | Pancreatitis | Urolithiasis | Cholangitis | Portal Hypertension | Cholelithiasis | Hydronephrosis | Abdominal Aortic Aneurysm | Abnormal Uterine Bleeding | Ovarian Torsion | Blunt Abdominal Trauma | Ovarian MassDominican Republic
-
Mayo ClinicWithdrawnOsteoarthritis | Inflammatory ArthritisUnited States
-
Allentown Anesthesia AssociatesSonoSite, Inc.CompletedTrauma to the Arm, Shoulder, Elbow, Forearm, or HandUnited States
-
Manuel C. VallejoCompleted
-
Yale UniversityCompletedUltrasonographyUnited States
-
Ascension Genesys HospitalCompletedMass CasualtyUnited States
-
VA Connecticut Healthcare SystemTerminatedOsteoarthritisUnited States
-
University of Alabama at BirminghamWithdrawn
-
The Hawkins FoundationCompleted
-
American University of Beirut Medical CenterCompletedTime Needed to Achieve a Successful Cannulation of the Femoral Artery in Pediatric Cardiac SurgeryLebanon