Quantification of Cerebral Perfusion by Contrast-enhanced Ultrasound During Neonatal Heart Surgery
- Conditions
- Heart Defects, Congenital
- Interventions
- Diagnostic Test: TCEUS
- Registration Number
- NCT03215628
- Lead Sponsor
- University of Erlangen-Nürnberg Medical School
- Brief Summary
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.
- Detailed 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 12
- 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)
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Group A - TCEUS with HLM TCEUS General neonatal cardiac surgery with HLM (art. switch, aortopulmonary shunts) Group B - TCEUS with HLM TCEUS Surgery of the aortic arc Group C - TCEUS without HLM TCEUS Neonatal cardiac surgery without HLM
- Primary Outcome Measures
Name Time Method Time-To-Peak (TTP) Intraoperative (Directly after start of surgical intervention (T1) vs. Directly before end of intervention (T5)) Relative/percentage difference of cerebral perfusion by TCEUS-based quantification using VueBox(R) software
Mean-Transit-Time (MTT) Intraoperative (Directly after start of surgical intervention (T1) vs. Directly before end of intervention (T5)) Relative/percentage difference of cerebral perfusion by TCEUS-based quantification using VueBox(R) software
Maximum Intensity (MI) Intraoperative (Directly after start of surgical intervention (T1) vs. Directly before end of intervention (T5)) Relative/percentage difference of cerebral perfusion by TCEUS-based quantification using VueBox(R) software
Relative Blood Volume (RBV) Intraoperative (Directly after start of surgical intervention (T1) vs. Directly before end of intervention (T5)) Relative/percentage difference of cerebral perfusion by TCEUS-based quantification using VueBox(R) software
Relative Blood Flow (RBF) Intraoperative (Directly after start of surgical intervention (T1) vs. Directly before end of intervention (T5)) Relative/percentage difference of cerebral perfusion by TCEUS-based quantification using VueBox(R) software
- Secondary Outcome Measures
Name Time Method Time-To-Peak (TTP) Directly after start of surgical intervention (T1) vs. Directly after low flow of HLM at 25-28°C/hypothermia (T4) Relative/percentage difference of cerebral perfusion by TCEUS-based quantification using VueBox(R) software
Mean-Transit-Time (MTT) Directly after start of surgical intervention (T1) vs. Directly after low flow of HLM at 25-28°C/hypothermia (T4) Relative/percentage difference of cerebral perfusion by TCEUS-based quantification using VueBox(R) software
Maximum Intensity (MI) Directly after start of surgical intervention (T1) vs. Directly after low flow of HLM at 25-28°C/hypothermia (T4) Relative/percentage difference of cerebral perfusion by TCEUS-based quantification using VueBox(R) software
Relative Blood Volume (RBV) Directly after start of surgical intervention (T1) vs. Directly after low flow of HLM at 25-28°C/hypothermia (T4) Relative/percentage difference of cerebral perfusion by TCEUS-based quantification using VueBox(R) software
Relative Blood Flow (RBF) Directly after start of surgical intervention (T1) vs. Directly after low flow of HLM at 25-28°C/hypothermia (T4) Relative/percentage difference of cerebral perfusion by TCEUS-based quantification using VueBox(R) software
Trial Locations
- Locations (1)
University Hospital of Erlangen-Nürnberg, Department of Pediatric Cardiac Surgery
🇩🇪Erlangen, Germany