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NCT01996020 Clinical Trial

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

Cardiopulmonary Arrest Clinical Trial

Official title:
Intraoperative Trans-fontanel Cerebral Ultrasonography in Infants During Pediatric Cardiac Surgery Under Cardiopulmonary Bypass

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01996020
Other study ID # H-1208-018-421
Secondary ID
Status Completed
Phase N/A
First received November 21, 2013
Last updated May 19, 2015
Start date September 2012
Est. completion date August 2014

Study information
Verified date May 2015
Source Seoul National University Hospital
Contact n/a
Is FDA regulated No
Health authority South Korea: Institutional Review Board
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 43
Est. completion date August 2014
Est. primary completion date July 2013
Accepts healthy volunteers No
Gender Both
Age group N/A to 1 Year
Eligibility Inclusion Criteria:

1. the patients less than 1 year of age undergo congenital heart surgery with cardiopulmonary bypass

2. written informed consent is obtained from their guardians in accordance with the requirements of the local ethics committee

Exclusion Criteria:

1. synostosis

2. skull abnormality or fracture

3. epidural hematoma, scalp hematoma

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
Korea, Republic of Seoul National University Hospital Seoul

Sponsors (1)
Lead Sponsor Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary cerebral blood flow velocity during cardiac surgery 6hour No
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