Clinical trial NCT03215628: Quantification of Cerebral Perfusion by Contrast-enhanced Ultrasound During Neonatal Heart Surgery
Official title: Quantifizierung Der Hirnperfusion Während Kinderherzchirurgischer Operationen Durch Transkraniellen Kontrastmittelverstärkten Ultraschall
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Defects, Congenital
Keywords: CEUS
TCEUS
contrast enhanced ultrasound
perfusion
cerebral perfusion
sulphur hexafluoride
SonoVue
Lead sponsor: University of Erlangen-Nürnberg Medical School
Sponsor class: OTHER
First posted: 2017-07-12
Enrollment: 12
Sex: ALL
Maximum age (years): 4
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

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

Primary outcomes:
measure: Time-To-Peak (TTP)
timeFrame: Intraoperative (Directly after start of surgical intervention (T1) vs. Directly before end of intervention (T5))
measure: Mean-Transit-Time (MTT)
timeFrame: Intraoperative (Directly after start of surgical intervention (T1) vs. Directly before end of intervention (T5))
measure: Maximum Intensity (MI)
timeFrame: Intraoperative (Directly after start of surgical intervention (T1) vs. Directly before end of intervention (T5))
measure: Relative Blood Volume (RBV)
timeFrame: Intraoperative (Directly after start of surgical intervention (T1) vs. Directly before end of intervention (T5))
measure: Relative Blood Flow (RBF)
timeFrame: Intraoperative (Directly after start of surgical intervention (T1) vs. Directly before end of intervention (T5))
Secondary outcomes:
measure: Time-To-Peak (TTP)
timeFrame: Directly after start of surgical intervention (T1) vs. Directly after full flow of HLM at 37°C (T2)
measure: Time-To-Peak (TTP)
timeFrame: Directly after start of surgical intervention (T1) vs. Directly after full flow of HLM at 25-28°C/hypothermia (T3)
measure: Time-To-Peak (TTP)
timeFrame: Directly after start of surgical intervention (T1) vs. Directly after low flow of HLM at 25-28°C/hypothermia (T4)
measure: Mean-Transit-Time (MTT)
timeFrame: Directly after start of surgical intervention (T1) vs. Directly after full flow of HLM at 37°C (T2)
measure: Mean-Transit-Time (MTT)
timeFrame: Directly after start of surgical intervention (T1) vs. Directly after full flow of HLM at 25-28°C/hypothermia (T3)
measure: Mean-Transit-Time (MTT)
timeFrame: Directly after start of surgical intervention (T1) vs. Directly after low flow of HLM at 25-28°C/hypothermia (T4)
measure: Maximum Intensity (MI)
timeFrame: Directly after start of surgical intervention (T1) vs. Directly after full flow of HLM at 37°C (T2)
measure: Maximum Intensity (MI)
timeFrame: Directly after start of surgical intervention (T1) vs. Directly after full flow of HLM at 25-28°C/hypothermia (T3)
measure: Maximum Intensity (MI)
timeFrame: Directly after start of surgical intervention (T1) vs. Directly after low flow of HLM at 25-28°C/hypothermia (T4)
measure: Relative Blood Volume (RBV)
timeFrame: Directly after start of surgical intervention (T1) vs. Directly after full flow of HLM at 37°C (T2)
measure: Relative Blood Volume (RBV)
timeFrame: Directly after start of surgical intervention (T1) vs. Directly after full flow of HLM at 25-28°C/hypothermia (T3)
measure: Relative Blood Volume (RBV)
timeFrame: Directly after start of surgical intervention (T1) vs. Directly after low flow of HLM at 25-28°C/hypothermia (T4)
measure: Relative Blood Flow (RBF)
timeFrame: Directly after start of surgical intervention (T1) vs. Directly after full flow of HLM at 37°C (T2)
measure: Relative Blood Flow (RBF)
timeFrame: Directly after start of surgical intervention (T1) vs. Directly after full flow of HLM at 25-28°C/hypothermia (T3)
measure: Relative Blood Flow (RBF)
timeFrame: Directly after start of surgical intervention (T1) vs. Directly after low flow of HLM at 25-28°C/hypothermia (T4)
Other outcomes:
Locations:
city: Erlangen
country: Germany
facility: University Hospital of Erlangen-Nürnberg, Department of Pediatric Cardiac Surgery
Study officials:
affiliation: University Hospital Erlangen, Department of Pediatric Cardiac Surgery
name: André Rüffer, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital Erlangen, Department of Pediatrics
name: Jörg Jüngert, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.