Ultrasound Measurement of RIJV in Patients Between 0-2 Years | NCT03604094

Studies
Ultrasound Measurement of RIJV in Patients Between 0-2 Years

NCT03604094

Sponsor

Hacettepe University

Status

Completed

Last Update Posted

Feb 21, 2020Actual

Enrollment

156Actual

Phase

Not provided

Conditions

Anatomic Abnormality
Internal Jugular Vein
Neonates
Infants, Premature
Children

Interventions

Ultrasonographic evaluation

Countries

Turkey (Türkiye)

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 1, 2018Actual

Primary Completion Date

Jul 1, 2019Actual

Completion Date

Jul 1, 2019Actual

First Submitted Date

Jul 19, 2018

First Submission Date that Met QC Criteria

Jul 19, 2018

First Posted Date

Jul 27, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 20, 2020

Last Update Posted Date

Feb 21, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

156Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Group I		0-1 month old newborns	Procedure: Ultrasonographic evaluation
Group II		1 month-2 year-old pediatric patients	Procedure: Ultrasonographic evaluation

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Ultrasonographic evaluation	Procedure	Right internal jugular vein will be evaluated with ultrasound for anatomical variations and dimensions	Group I Group II

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Anatomical variations and dimensions of right internal jugular vein	The central vein will be evaluated by ultrasound	1 year

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

0-2 years Elective surgery Requirement for central venous cannulation

Exclusion Criteria:

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

2 Years

Standard Ages

Child

Study Population

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

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Filiz Uzumcugil		Ankara		06100	Turkey (Türkiye)

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D000013	Congenital Abnormalities
D047928	Premature Birth

Ancestor Terms

ID	Term
D009358	Congenital, Hereditary, and Neonatal Diseases and Abnormalities
D007752	Obstetric Labor, Premature
D007744	Obstetric Labor Complications
D011248	Pregnancy Complications

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Browse Branches

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