NCT03604094

Brief Summary

After obtaining parental consent ultrasonographic evaluation of right internal jugular vein will be performed in pediatric patients undergoing elective surgeries between 0-2 years of age. The patients for whom central venous catheterization is indicated will be included. The success rates and outcomes of catheterization will be recorded.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
156

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2018

Shorter than P25 for all trials

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

Study Start

First participant enrolled

July 1, 2018

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

July 19, 2018

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 27, 2018

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2019

Completed
Last Updated

February 21, 2020

Status Verified

February 1, 2020

Enrollment Period

1 year

First QC Date

July 19, 2018

Last Update Submit

February 20, 2020

Conditions

Anatomic AbnormalityInternal Jugular VeinNeonatesInfants, PrematureChildren

Keywords

central venous catheter, pediatrics, ultrasound imaging

Outcome Measures

Primary Outcomes (1)

  • Anatomical variations and dimensions of right internal jugular vein

    The central vein will be evaluated by ultrasound

    1 year

Study Arms (2)

Group I

0-1 month old newborns

Procedure: Ultrasonographic evaluation

Group II

1 month-2 year-old pediatric patients

Procedure: Ultrasonographic evaluation

Interventions

Ultrasonographic evaluationPROCEDURE

Right internal jugular vein will be evaluated with ultrasound for anatomical variations and dimensions

Group IGroup II

Eligibility Criteria

AgeUp to 2 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

Healthy 0-2 year-old patients undergoing elective surgery.

You may qualify if:

  • years Elective surgery Requirement for central venous cannulation

You may not qualify if:

  • Congenital cardiovascular anomalies Emergency surgeries Previous cannulation or any intervention on the neck

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Filiz Uzumcugil

Ankara, 06100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Congenital AbnormalitiesPremature Birth

Condition Hierarchy (Ancestors)

Congenital, Hereditary, and Neonatal Diseases and AbnormalitiesObstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, Asist. Prof.

Study Record Dates

First Submitted

July 19, 2018

First Posted

July 27, 2018

Study Start

July 1, 2018

Primary Completion

July 1, 2019

Study Completion

July 1, 2019

Last Updated

February 21, 2020

Record last verified: 2020-02

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)