Estimation of Internal Jugular Vein Central Venous Pressu... | NCT00904358

Studies
Estimation of Internal Jugular Vein Central Venous Pressure (CVP) by Ultrasound

NCT00904358

Sponsor

Mahidol University

Status

Completed

Last Update Posted

Jun 6, 2017Actual

Enrollment

130Actual

Phase

Not provided

Conditions

Internal Jugular Size Measured by Ultrasound
Central Venous Pressure

Interventions

cross sectional area

Countries

Thailand

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

Jun 2017

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

May 2009Actual

Primary Completion Date

Mar 2010Actual

Completion Date

Mar 2010Actual

First Submitted Date

May 15, 2009

First Submission Date that Met QC Criteria

May 18, 2009

First Posted Date

May 19, 2009Estimated

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

Jun 4, 2017

Last Update Posted Date

Jun 6, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

To study the validity and reliability of estimation of the central venous pressure by measurement of internal jugular vein size using 2-dimensional ultrasound.

Detailed Description

Objectives:

To study the validity and reliability of estimation of the central venous pressure by measurement of internal jugular vein size using 2-dimensional ultrasound.
To evaluate the correlation of internal jugular vein cross sectional area and central venous pressure.

Methods:

The study design is prospective observational study.
We will include all patients scheduled for cardiac surgery in Siriraj Hospital and record both internal jugular size using 2-dimensional ultrasound just before central venous catheter insertion. The central venous pressure will be recorded and the ultrasound picture will be measured.
The data will be analyzed.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

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

130Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
cross sectional area		internal jugular cross sectional area measured by ultrasound	Diagnostic Test: cross sectional area

Interventions

Name	Type	Description	Arm Group Labels	Other Names
cross sectional area	Diagnostic Test		cross sectional area

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
internal jugular size	Cross-sectional area of internal jugular vein measured by ultrasound	1 day

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

patients scheduled for cardiac surgery
need central venous catheterization intraoperatively
elective surgery
age > 18

Exclusion Criteria:

neck pathology
history of internal jugular or SVC thrombosis
limited neck mobility
severe valvular lesion
decompensated heart failure

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

patients scheduled for cardiac surgery in Siriraj Hospital

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Kasana Raksamani, MD	Mahidol University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Faculty of Medicine, Siriraj Hospital		Bangkok		10700	Thailand
Kasana Raksamani