Needle Puncture Point During Central Venous Catheterizati... | NCT04916288

Studies
Needle Puncture Point During Central Venous Catheterization With Ultrasound Guidance

NCT04916288

Sponsor

Seoul National University Hospital

Status

Unknown status

Last Update Posted

Aug 16, 2021Actual

Enrollment

112Estimated

Phase

Not provided

Conditions

Central Venous Catheterization

Interventions

central venous cathterization

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 2021

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 16, 2021Estimated

Primary Completion Date

Jul 16, 2022Estimated

Completion Date

Aug 16, 2022Estimated

First Submitted Date

Jun 1, 2021

First Submission Date that Met QC Criteria

Jun 1, 2021

First Posted Date

Jun 7, 2021Actual

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 12, 2021

Last Update Posted Date

Aug 16, 2021Actual

Name	Class
SMG-SNU Boramae Medical Center	OTHER

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

In this observational study, we will measure the shortest distance from the cricoid cartilage level to the puncture site of the introducer needle when anesthesiologists perform central venous catheterization.

Detailed Description

After anesthesia induction and tracheal intubation, we will prepare central venous catheterization for patients requiring it. After anesthesiologists who are blinded to this study perform central venous catheterization, an investigator measured the shortest distance from the crease line of the cricoid cartilage to the puncture site of the introducer needle.

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

112Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
central venous cathterization	Device	central venous catheterization through the right internal jugular vein

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
puncture site	distance from the crease line of the cricoid cartilage to the puncture site of the introducer needle	intraoperative

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

elective surgery under general anesthesia
requirement of central venous catheterization

Exclusion Criteria:

disagreement for participation

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Adult patients (>18 years old) scheduled to elective surgery requiring central venous catheterization under general anesthesia.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Jung-Man Lee, MD.PhD	Contact	+82-2-870-2513		jungman007@gmail.com

Overall Officials

Name	Affiliation	Role
Jung-Man Lee, MD.PhD	SMG-SNU Boramae Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Seoul Metropolitan Government Seoul National University Boramae Medical Center		Seoul		07061	South Korea

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

If there would be a proper reason, I will share the data to other researchers.

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided