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

Heart Defects, Congenital Clinical Trial

— TCEUS  

Official title:

Quantifizierung Der Hirnperfusion Während Kinderherzchirurgischer Operationen Durch Transkraniellen Kontrastmittelverstärkten Ultraschall

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03215628
• Other study ID #: 20_17B
• Status: Completed
• Phase: N/A
• Start date: July 4, 2017
• Est. completion date: August 30, 2021

Study information

• Verified date: November 2020
• Source: University of Erlangen-Nürnberg Medical School
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: August 30, 2021
• Est. primary completion date: June 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 4 Months

Eligibility

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

Related Conditions & MeSH terms

• Congenital Abnormalities
• Heart Defects, Congenital

Intervention

Diagnostic Test:
• TCEUS
Intravenous sulphur hexafluoride microbubbles

Locations

Country	Name	City	State
Germany	University Hospital of Erlangen-Nürnberg, Department of Pediatric Cardiac Surgery	Erlangen

Sponsors (1)

Lead Sponsor	Collaborator
University of Erlangen-Nürnberg Medical School

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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))
Primary	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))
Primary	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))
Primary	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))
Primary	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))
Secondary	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)
Secondary	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 25-28°C/hypothermia (T3)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)