Heart Defects, Congenital
Conditions
Keywords
CEUS, TCEUS, contrast enhanced ultrasound, perfusion, cerebral perfusion, sulphur hexafluoride, SonoVue
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.
Interventions
DIAGNOSTIC_TESTTCEUS
Intravenous sulphur hexafluoride microbubbles
Sponsors
University of Erlangen-Nürnberg Medical School
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
No minimum to 4 Months
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time-To-Peak (TTP) | Directly after start of surgical intervention (T1) vs. Directly after full flow of HLM at 37°C (T2) | 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 full flow of HLM at 37°C (T2) | 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 full flow of HLM at 37°C (T2) | 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 full flow of HLM at 37°C (T2) | 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 full flow of HLM at 37°C (T2) | Relative/percentage difference of cerebral perfusion by TCEUS-based quantification using VueBox(R) software |
Countries
Germany
Outcome results
None listed