NCT01996020

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
43

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2012

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2012

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2013

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

November 21, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 27, 2013

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2014

Completed
Last Updated

May 21, 2015

Status Verified

May 1, 2015

Enrollment Period

10 months

First QC Date

November 21, 2013

Last Update Submit

May 19, 2015

Conditions

Cardiopulmonary Arrest

Outcome Measures

Primary Outcomes (1)

  • cerebral blood flow velocity

    during cardiac surgery

    6hour

Eligibility Criteria

AgeUp to 1 Year
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • synostosis
  • skull abnormality or fracture
  • epidural hematoma, scalp hematoma

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital

Seoul, 110-744, South Korea

Location

Related Publications (1)

  • 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.

    PMID: 26691513DERIVED

MeSH Terms

Conditions

Heart Arrest

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor

Study Record Dates

First Submitted

November 21, 2013

First Posted

November 27, 2013

Study Start

September 1, 2012

Primary Completion

July 1, 2013

Study Completion

August 1, 2014

Last Updated

May 21, 2015

Record last verified: 2015-05

Locations

KR(1)