Validation of the Ipsilateral Nipple as the Directional G... | NCT01347463

Studies
Validation of the Ipsilateral Nipple as the Directional Guide for Internal Jugular Vein (IJV) Catheterization

NCT01347463

Sponsor

Seoul National University Hospital

Status

Completed

Last Update Posted

Aug 5, 2020Actual

Enrollment

100Actual

Phase

Not provided

Conditions

Ipsilateral Nipple
Internal Jugular Vein
Catheterization

Interventions

SCM triangle - ipsilateral nipple

Countries

South Korea

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

Aug 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

Jun 2011

Primary Completion Date

Dec 2011Actual

Completion Date

Dec 2011Actual

First Submitted Date

Apr 29, 2011

First Submission Date that Met QC Criteria

May 3, 2011

First Posted Date

May 4, 2011Estimated

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

Aug 3, 2020

Last Update Posted Date

Aug 5, 2020Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Ho Geol Ryu, Assistant professor, Seoul National University HospitalPrincipal Investigator

Lead Sponsor

Seoul National University HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

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

Traditional teaching that suggests the ipsilateral nipple as the directional guide for needle advancement during Internal Jugular Vein (IJV) catheterization has weak grounds.

The investigators attempt to validate this long-standing statement.

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

100Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Traditional			Procedure: SCM triangle - ipsilateral nipple

Interventions

Name	Type	Description	Arm Group Labels	Other Names
SCM triangle - ipsilateral nipple	Procedure	draws the tract of the IJV using the SCM triangle head and the ipsilateral nipple	Traditional

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
difference in angle	difference in angle between traditional (triangular head of the SCM - ipsilateral nipple) and ultrasound guided tract	1 day

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

adult patients over the age of 18 undergoing general anesthesia

Exclusion Criteria:

history of neck or breast surgery
anatomical anomaly of the neck or breast
neck mass
breast mass

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

patients scheduled to undergo general anesthesia

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Boramae Medical Center		Seoul		156-707	South Korea