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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A - TCEUS with HLM | Active Comparator | General neonatal cardiac surgery with HLM (art. switch, aortopulmonary shunts) |
|
| Group B - TCEUS with HLM | Experimental | Surgery of the aortic arc |
|
| Group C - TCEUS without HLM | Active Comparator | Neonatal cardiac surgery without HLM |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TCEUS | Diagnostic Test | Intravenous sulphur hexafluoride microbubbles |
|
| Measure | Description | Time Frame |
|---|---|---|
| Time-To-Peak (TTP) | Relative/percentage difference of cerebral perfusion by TCEUS-based quantification using VueBox(R) software | 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 | 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 | 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 | 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 | Intraoperative (Directly after start of surgical intervention (T1) vs. Directly before end of intervention (T5)) |
| Measure | Description | Time Frame |
|---|---|---|
| Time-To-Peak (TTP) | Relative/percentage difference of cerebral perfusion by TCEUS-based quantification using VueBox(R) software | Directly after start of surgical intervention (T1) vs. Directly after full flow of HLM at 37°C (T2) |
| Time-To-Peak (TTP) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| André Rüffer, MD | University Hospital Erlangen, Department of Pediatric Cardiac Surgery | Principal Investigator |
| Jörg Jüngert, MD | University Hospital Erlangen, Department of Pediatrics | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital of Erlangen-Nürnberg, Department of Pediatric Cardiac Surgery | Erlangen | 91054 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35380495 | Derived | Knieling F, Cesnjevar R, Regensburger AP, Wagner AL, Purbojo A, Dittrich S, Munch F, Neubert A, Woelfle J, Jungert J, Ruffer A. Transfontanellar Contrast-enhanced US for Intraoperative Imaging of Cerebral Perfusion during Neonatal Arterial Switch Operation. Radiology. 2022 Jul;304(1):164-173. doi: 10.1148/radiol.212044. Epub 2022 Apr 5. | |
| 34718510 |
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| ID | Term |
|---|---|
| D006330 | Heart Defects, Congenital |
| ID | Term |
|---|---|
| D018376 | Cardiovascular Abnormalities |
| D002318 | Cardiovascular Diseases |
| D006331 | Heart Diseases |
| D000013 | Congenital Abnormalities |
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|
Relative/percentage difference of cerebral perfusion by TCEUS-based quantification using VueBox(R) software
| Directly after start of surgical intervention (T1) vs. Directly after full flow of HLM at 25-28°C/hypothermia (T3) |
| Time-To-Peak (TTP) | Relative/percentage difference of cerebral perfusion by TCEUS-based quantification using VueBox(R) software | Directly after start of surgical intervention (T1) vs. Directly after low flow of HLM at 25-28°C/hypothermia (T4) |
| Mean-Transit-Time (MTT) | Relative/percentage difference of cerebral perfusion by TCEUS-based quantification using VueBox(R) software | Directly after start of surgical intervention (T1) vs. Directly after full flow of HLM at 37°C (T2) |
| Mean-Transit-Time (MTT) | Relative/percentage difference of cerebral perfusion by TCEUS-based quantification using VueBox(R) software | Directly after start of surgical intervention (T1) vs. Directly after full flow of HLM at 25-28°C/hypothermia (T3) |
| Mean-Transit-Time (MTT) | Relative/percentage difference of cerebral perfusion by TCEUS-based quantification using VueBox(R) software | Directly after start of surgical intervention (T1) vs. Directly after low flow of HLM at 25-28°C/hypothermia (T4) |
| Maximum Intensity (MI) | Relative/percentage difference of cerebral perfusion by TCEUS-based quantification using VueBox(R) software | Directly after start of surgical intervention (T1) vs. Directly after full flow of HLM at 37°C (T2) |
| Maximum Intensity (MI) | Relative/percentage difference of cerebral perfusion by TCEUS-based quantification using VueBox(R) software | Directly after start of surgical intervention (T1) vs. Directly after full flow of HLM at 25-28°C/hypothermia (T3) |
| Maximum Intensity (MI) | Relative/percentage difference of cerebral perfusion by TCEUS-based quantification using VueBox(R) software | Directly after start of surgical intervention (T1) vs. Directly after low flow of HLM at 25-28°C/hypothermia (T4) |
| Relative Blood Volume (RBV) | Relative/percentage difference of cerebral perfusion by TCEUS-based quantification using VueBox(R) software | Directly after start of surgical intervention (T1) vs. Directly after full flow of HLM at 37°C (T2) |
| Relative Blood Volume (RBV) | Relative/percentage difference of cerebral perfusion by TCEUS-based quantification using VueBox(R) software | Directly after start of surgical intervention (T1) vs. Directly after full flow of HLM at 25-28°C/hypothermia (T3) |
| Relative Blood Volume (RBV) | Relative/percentage difference of cerebral perfusion by TCEUS-based quantification using VueBox(R) software | Directly after start of surgical intervention (T1) vs. Directly after low flow of HLM at 25-28°C/hypothermia (T4) |
| Relative Blood Flow (RBF) | Relative/percentage difference of cerebral perfusion by TCEUS-based quantification using VueBox(R) software | Directly after start of surgical intervention (T1) vs. Directly after full flow of HLM at 37°C (T2) |
| Relative Blood Flow (RBF) | Relative/percentage difference of cerebral perfusion by TCEUS-based quantification using VueBox(R) software | Directly after start of surgical intervention (T1) vs. Directly after full flow of HLM at 25-28°C/hypothermia (T3) |
| Relative Blood Flow (RBF) | Relative/percentage difference of cerebral perfusion by TCEUS-based quantification using VueBox(R) software | Directly after start of surgical intervention (T1) vs. Directly after low flow of HLM at 25-28°C/hypothermia (T4) |
| Ruffer A, Knieling F, Cesnjevar R, Regensburger A, Purbojo A, Dittrich S, Munch F, Wolfle J, Jungert J. Equal cerebral perfusion during extended aortic coarctation repair. Eur J Cardiothorac Surg. 2022 Jan 24;61(2):299-306. doi: 10.1093/ejcts/ezab415. |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |