Changes of Dorsalis Pedis Artery Flow Pattern After Cauda... | NCT01107873

Studies
Changes of Dorsalis Pedis Artery Flow Pattern After Caudal Block in Children: Observational Study Using a Duplex Sonography

NCT01107873

Sponsor

Yonsei University

Status

Completed

Last Update Posted

Oct 7, 2010Estimated

Enrollment

20Actual

Phase

Not provided

Conditions

Anesthesia, Caudal

Interventions

Not provided

Countries

Not provided

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

Oct 2010

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 2010

Primary Completion Date

Jun 2010Actual

Completion Date

Jun 2010Actual

First Submitted Date

Apr 19, 2010

First Submission Date that Met QC Criteria

Apr 19, 2010

First Posted Date

Apr 21, 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

Oct 6, 2010

Last Update Posted Date

Oct 7, 2010Estimated

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

The purpose of this study is to determine the changes of Dorsalis Pedis Artery Flow Pattern after Caudal Block in Children: Observational Study Using a Duplex Sonography.

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

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

20Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
duplex ultrasonography		conduct duplex ultrasonography after caudal block with sevoflurane anaesthesia in children

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Investigation of arterial hemodynamics	Investigation of arterial hemodynamics included peak systolic velocity [PS], end diastolic velocity [ED], mean velocity [MV], time-averaged maximum velocity [TAmax], time-averaged mean velocity [TAmean], pulsatility index [PI], volume flow [VF], and dorsalis pedis artery diameter [D].

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Twenty (ASA status I) unpremedicated children, ages 1 to 5 yr old, who were scheduled for a day-case urologic surgery

Exclusion Criteria:

if there were contraindications for caudal block including hypersensitivity to any local anaesthetics, bleeding diathesis, infections at the puncture sites, or pre-existing neurological disease.

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

1 Year

Maximum Age

5 Years

Standard Ages

Child

Study Population

children patients who visit Severance hospital

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Hae Keum Kil	Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine, Seoul, Korea	Principal Investigator

Locations

Not provided