Internal Carotid Artery Blood Flow in Infants With Prone... | NCT05391282

Studies
Internal Carotid Artery Blood Flow in Infants With Prone Position

NCT05391282

Sponsor

Seoul National University Hospital

Status

Unknown status

Last Update Posted

May 31, 2022Actual

Enrollment

20Estimated

Phase

Not provided

Conditions

Cerebral Lesion

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

May 2022

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 23, 2022Estimated

Primary Completion Date

Dec 23, 2023Estimated

Completion Date

Dec 23, 2023Estimated

First Submitted Date

May 20, 2022

First Submission Date that Met QC Criteria

May 20, 2022

First Posted Date

May 25, 2022Actual

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 24, 2022

Last Update Posted Date

May 31, 2022Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Eun-hee Kim, Clinical associate professor, Seoul National University HospitalPrincipal Investigator

Lead Sponsor

Seoul National University HospitalOTHER

Collaborators

Not provided

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 implementation of prone position contributes to general anesthesia-induced decrease in cerebral blood flow in infants. The investigators investigated this question in participants undergoing untethering, 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

20Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
ultrasound assessment	Other	Transfontanel ultrasound assessment before and after prone positioning

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Changes of internal carotid artery blood flow velocity		from induction of anesthesia to end of operation, about 3 hours

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

pediatric neurosurgical patients receiving surgery under prone position

Exclusion Criteria:

patients diagnosed as hydrocephalus
premature closure of fontanelle
patients diagnosed as patent ductus arteriosus or other congenital heart disease.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

15 Months

Standard Ages

Child

Study Population

pediatric neurosurgical patients

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Eun-hee Kim	Contact	+82-2-2072-3664		beloveun@snu.ac.kr

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Seoul national university hospital		Seoul			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