Quantifizierung Der Hirnperfusion Während Kinderherzchirurgischer Operationen Durch Transkraniellen Kontrastmittelverstärkten Ultraschall
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Heart Defects, Congenital
- Sponsor
- University of Erlangen-Nürnberg Medical School
- Enrollment
- 12
- Locations
- 1
- Primary Endpoint
- Time-To-Peak (TTP)
- Status
- Completed
- Last Updated
- 4 years ago
Overview
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.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Time-To-Peak (TTP)
Time Frame: 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)
Time Frame: 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)
Time Frame: 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)
Time Frame: 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)
Time Frame: 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 Outcomes
- Time-To-Peak (TTP)(Directly after start of surgical intervention (T1) vs. Directly after low flow of HLM at 25-28°C/hypothermia (T4))
- Mean-Transit-Time (MTT)(Directly after start of surgical intervention (T1) vs. Directly after low flow of HLM at 25-28°C/hypothermia (T4))
- Maximum Intensity (MI)(Directly after start of surgical intervention (T1) vs. Directly after low flow of HLM at 25-28°C/hypothermia (T4))
- 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 Blood Flow (RBF)(Directly after start of surgical intervention (T1) vs. Directly after low flow of HLM at 25-28°C/hypothermia (T4))