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

University of Erlangen-Nürnberg Medical School

Status: Completed

Conditions: Heart Defects, Congenital

Treatments: Diagnostic Test: TCEUS

Study type: Interventional

Funder types: Other

Identifiers

NCT03215628

20_17B

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 12 patients

Sex: All

Ages: Under 4 months old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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12 participants in 3 patient groups

Group A - TCEUS with HLM

Active Comparator group

Description:

General neonatal cardiac surgery with HLM (art. switch, aortopulmonary shunts)

Treatment:

Diagnostic Test: TCEUS

Group B - TCEUS with HLM

Experimental group

Description:

Surgery of the aortic arc

Treatment:

Diagnostic Test: TCEUS

Group C - TCEUS without HLM

Active Comparator group

Description:

Neonatal cardiac surgery without HLM

Treatment:

Diagnostic Test: TCEUS