Internal Carotid Artery Blood Flow in Pediatric Moyamoya... | NCT04134221

Studies
Internal Carotid Artery Blood Flow in Pediatric Moyamoya Patients

NCT04134221

Sponsor

Seoul National University Hospital

Status

Completed

Last Update Posted

Apr 21, 2021Actual

Enrollment

30Actual

Phase

Not provided

Conditions

Carotid Artery, Internal

Interventions

Ultrasound assessment

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 2021

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

Oct 18, 2019Actual

Primary Completion Date

Feb 17, 2021Actual

Completion Date

Feb 17, 2021Actual

First Submitted Date

Oct 18, 2019

First Submission Date that Met QC Criteria

Oct 18, 2019

First Posted Date

Oct 22, 2019Actual

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 19, 2021

Last Update Posted Date

Apr 21, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

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

Little is known about how general anesthesia-induced decrease in cerebral blood flow in pediatric moyamoya pateints. We investigated this question in patients undergoing moyamoya surgery, hypothesizing that cardiorespiratory changes during this procedure would reduce cerebral perfusion.

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

30Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Ultrasound assessment	Diagnostic Test	Ultrasound assessment of internal carotid artery blood flow

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Internal carotid artery blood flow velocity	ultrasound assessment of internal carotid artery blood flow velocity	from anesthetic induction to end of surgery, an average of 5 hours

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

pediatric patients undergoing encephaloduroarteriosynangiosis surgery for moyamoya disease

Exclusion Criteria:

cutaneous lesion on the neck

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

18 Years

Standard Ages

ChildAdult

Study Population

pediatric Moyamoya disease patients

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hee-Soo Kim		Seoul	Soul-t'ukpyolsi	03080	South Korea

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided