Measurement of Cerebral Flow Using Transfontanellar Doppl... | NCT01996020

Studies
Measurement of Cerebral Flow Using Transfontanellar Doppler in Infants Under Cardiopulmonary Bypass

NCT01996020

Sponsor

Seoul National University Hospital

Status

Completed

Last Update Posted

May 21, 2015Estimated

Enrollment

43Actual

Phase

Not provided

Conditions

Cardiopulmonary Arrest

Interventions

Not provided

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 2015

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

Sep 2012

Primary Completion Date

Jul 2013Actual

Completion Date

Aug 2014Actual

First Submitted Date

Nov 21, 2013

First Submission Date that Met QC Criteria

Nov 26, 2013

First Posted Date

Nov 27, 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 19, 2015

Last Update Posted Date

May 21, 2015Estimated

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)

Yes

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

Transfontanellar Doppler can measure the velocity at both the carotid artery and the anterior cerebral artery during cardiopulmonary bypass in congenital heart disease patients. This study can provide reference value of appropriate cerebral blood flow velocity during pediatric cardiac surgery.

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

43Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
cerebral blood flow velocity	during cardiac surgery	6hour

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

the patients less than 1 year of age undergo congenital heart surgery with cardiopulmonary bypass
written informed consent is obtained from their guardians in accordance with the requirements of the local ethics committee

Exclusion Criteria:

synostosis
skull abnormality or fracture
epidural hematoma, scalp hematoma

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

pediatric patients with congenital heart disease scheduled to recieve cardiac surgery under CPB

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Seoul National University Hospital		Seoul		110-744	South Korea

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
26691513	Derived	Park YH, Song IK, Lee JH, Kim HS, Kim CS, Kim JT. Intraoperative trans-fontanellar cerebral ultrasonography in infants during cardiac surgery under cardiopulmonary bypass: an observational study. J Clin Monit Comput. 2017 Feb;31(1):159-165. doi: 10.1007/s10877-015-9815-3. Epub 2015 Dec 21.

ID	Term
D006331	Heart Diseases
D002318	Cardiovascular Diseases