Effects of Increased Tidal Volume on Internal Jugular Vei... | NCT01154660

Studies
Effects of Increased Tidal Volume on Internal Jugular Vein Cross-sectional Area

NCT01154660

Sponsor

Yonsei University

Status

Completed

Last Update Posted

Apr 19, 2011Estimated

Enrollment

40Actual

Phase

Not Applicable

Conditions

General Anesthesia
Surgery

Interventions

Tidal Volume

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

Apr 2011

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 2010

Primary Completion Date

Nov 2010Actual

Completion Date

Dec 2010Actual

First Submitted Date

Jun 30, 2010

First Submission Date that Met QC Criteria

Jun 30, 2010

First Posted Date

Jul 1, 2010Estimated

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

Apr 18, 2011

Last Update Posted Date

Apr 19, 2011Estimated

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

As increasing tidal volume, the cross sectional area and circumference of Internal Jugular Vein (IJV) could increase. And In the previous study, Trendelenburg position can increase size of IJV. So investigators would compare the cross sectional area, circumference of IJV and peak airway pressure in neutral and Trendelenburg position

Detailed Description

Not provided

Design Module

Study Type

Interventional

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 Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Neutral	Experimental		Other: Tidal Volume
Trendelenberg	Active Comparator		Other: Tidal Volume

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Tidal Volume	Other	observation of IJV circumference and cross sectional area using ultrasonography by changing of tidal volume	Neutral Trendelenberg

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

patients who are undergoing general anesthesia

Exclusion Criteria:

history of IJV cannulation
uncontrolled cardiovascular disease
severe pulmonary problem
cervical spinal impairment

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

25 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Severance Hospital, Anesthesiology & Pain Medicine		Seoul		120-752	South Korea

Intervention Browse Module

MeSH Terms

ID	Term
D013990	Tidal Volume

Ancestor Terms

ID	Term
D007320	Inspiratory Capacity
D014797	Vital Capacity
D014109	Total Lung Capacity
D008176	Lung Volume Measurements

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Browse Branches

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