Variation of Cerebral Blood Flow in Anterior Cerebral and... | NCT02761954

Studies
Variation of Cerebral Blood Flow in Anterior Cerebral and Basilar Artery in Neonates and Infants in Genreal Anesthesia With Caudal Block

NCT02761954

Sponsor

Bürgerhospital Frankfurt

Status

Completed

Last Update Posted

Jul 11, 2018Actual

Enrollment

50Actual

Phase

Not provided

Conditions

Pediatric Anesthesia

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

Jul 2018

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 2016

Primary Completion Date

Dec 20, 2017Actual

Completion Date

Dec 20, 2017Actual

First Submitted Date

May 2, 2016

First Submission Date that Met QC Criteria

May 2, 2016

First Posted Date

May 4, 2016Estimated

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

Jul 10, 2018

Last Update Posted Date

Jul 11, 2018Actual

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

With this study we want to see how the blood flow in the anterior cerebral artery (ACA) and the basilar artery (BA) after the caudal block changes.

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

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

50Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
depression of blood flow in ACA & basilar artery after caudal block		one hour

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

opened big fontanella
infraumbilical surgery

Exclusion Criteria:

cardiac or cerebral disease
prior operation on vertebra, heart or head/brain
malforamtion of head or vertebra
closed fontanella
contraindication for caudal block (von-Willebrand-Syndrome, haemophilia,...)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

12 Months

Standard Ages

Child

Study Population

infants and neonates undergoing a infraumbilical surgery in general anesthesia with caudal block

Sampling Method

Non-Probability Sample

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided