The Practical Use of Transthoracic Echocardiography for O... | NCT01763229

Status Module

Record Verification Date

May 2014

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

Jan 2012

Primary Completion Date

Mar 2013Actual

Completion Date

Mar 2013Actual

First Submitted Date

Jan 5, 2013

First Submission Date that Met QC Criteria

Jan 5, 2013

First Posted Date

Jan 8, 2013Estimated

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

May 12, 2014

Last Update Posted Date

May 14, 2014Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Jin-Tae Kim, 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

To test if transthoracic echocardiography is useful for correct positioning of central venous catheters in infants with congenital heart disease

Detailed Description

Patients scheduled for surgery for congenital heart disease younger than 12 months were studied. Following successful catheter insertion, the insertion depth was determined using transthoracic echocardiography. The long axis or short axis images were used.Chest X-ray images were taken postoperatively and distances from the tip to the carina level were measured.

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

108Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
transthoracic echocardiography	Experimental		Procedure: transthoracic echocardiography

Interventions

Name	Type	Description	Arm Group Labels	Other Names
transthoracic echocardiography	Procedure		transthoracic echocardiography

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
the distance between the catheter tip and the carina		After opearation (about 4-6 hour after insertion of the catheter)

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

scheduled for surgery under general anesthesia

Exclusion Criteria:

anomaly of the internal jugular vein
thrombus in the internal jugular vein

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

1 Year

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Derived Section

Miscellaneous Info Module

Version Holder

Jul 10, 2026

Removed Countries

Not provided

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

No data available

No data is available for this block.

Intervention Browse Module

No data available

No data is available for this block.