NCT03215628 - Quantification of Cerebral Perfusion by Contrast-enhanced Ultrasound During Neonatal Heart Surgery | Crick | Crick

Quantification of Cerebral Perfusion by Contrast-enhanced Ultrasound During Neonatal Heart Surgery

N/ACompletedNCT03215628

University of Erlangen-Nürnberg Medical School12 enrolled

Overview

Transcranial contrast-enhanced ultrasound for evaluation of cerebral blood flow during pediatric cardiac surgery. This study is aimed as a feasibility study prior to conducting a lager prospective clinical trial including neurologic and developmental outcome measures.

The cerebral perfusion of infants with congenital heart defects is a critical determinant during cardiac surgery. The majority of these interventions is performed during deep or moderate hypothermia (25-32°C) with reduced blood flow of the heart-lung-machine (HLM). Assuming a symmetrical anatomy of the cerebral arteries (C. Willisii) a single vessel (T. brachiocephalicus) is then supplying the cerebral blood flow. Using contrast-enhanced ultrasound the cerebral blood flow will be assessed during cardiac surgery interventions.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

12

Conditions

Heart Defects, Congenital

Interventions

TCEUSDIAGNOSTIC_TEST

Intravenous sulphur hexafluoride microbubbles

Eligibility

Sex: ALLMax age: 4 Months

Medical Language ↔ Plain English

Inclusion Criteria: * Neonates and infants ≤ 4 month (open fontanelle) * Proper ultrasound conditions/window * Appropriate general and neurologic state of health * Written consent of both parents/guardians * Availability of trained sonographer (medical doctor) Exclusion Criteria: * Absence of trained sonographer (medical doctor) * Intolerance against SonoVue® (bzw. sulphur hexafluoride) * Missing signed consent * Reduced or inappropriate general and neurologic state of health * Preexisting cerebral injury

Locations (1)

University Hospital of Erlangen-Nürnberg, Department of Pediatric Cardiac Surgery

Erlangen, Germany

Outcomes

Primary Outcomes

Time-To-Peak (TTP)

Relative/percentage difference of cerebral perfusion by TCEUS-based quantification using VueBox(R) software

Time frame: Intraoperative (Directly after start of surgical intervention (T1) vs. Directly before end of intervention (T5))

Mean-Transit-Time (MTT)

Relative/percentage difference of cerebral perfusion by TCEUS-based quantification using VueBox(R) software

Time frame: Intraoperative (Directly after start of surgical intervention (T1) vs. Directly before end of intervention (T5))

Maximum Intensity (MI)

Relative/percentage difference of cerebral perfusion by TCEUS-based quantification using VueBox(R) software

Time frame: Intraoperative (Directly after start of surgical intervention (T1) vs. Directly before end of intervention (T5))

Relative Blood Volume (RBV)

Relative/percentage difference of cerebral perfusion by TCEUS-based quantification using VueBox(R) software

Time frame: Intraoperative (Directly after start of surgical intervention (T1) vs. Directly before end of intervention (T5))

Relative Blood Flow (RBF)

Relative/percentage difference of cerebral perfusion by TCEUS-based quantification using VueBox(R) software

Time frame: Intraoperative (Directly after start of surgical intervention (T1) vs. Directly before end of intervention (T5))

Secondary Outcomes

Time-To-Peak (TTP)

Relative/percentage difference of cerebral perfusion by TCEUS-based quantification using VueBox(R) software

Time frame: Directly after start of surgical intervention (T1) vs. Directly after full flow of HLM at 37°C (T2)

Data from ClinicalTrials.gov

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