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

Primary Purpose

Heart Defects, Congenital

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
TCEUS
Sponsored by
University of Erlangen-Nürnberg Medical School
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Heart Defects, Congenital focused on measuring CEUS, TCEUS, contrast enhanced ultrasound, perfusion, cerebral perfusion, sulphur hexafluoride, SonoVue

Eligibility Criteria

undefined - 4 Months (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University Hospital of Erlangen-Nürnberg, Department of Pediatric Cardiac Surgery

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Active Comparator

Arm Label

Group A - TCEUS with HLM

Group B - TCEUS with HLM

Group C - TCEUS without HLM

Arm Description

General neonatal cardiac surgery with HLM (art. switch, aortopulmonary shunts)

Surgery of the aortic arc

Neonatal cardiac surgery without HLM

Outcomes

Primary Outcome Measures

Time-To-Peak (TTP)
Relative/percentage difference of cerebral perfusion by TCEUS-based quantification using VueBox(R) software
Mean-Transit-Time (MTT)
Relative/percentage difference of cerebral perfusion by TCEUS-based quantification using VueBox(R) software
Maximum Intensity (MI)
Relative/percentage difference of cerebral perfusion by TCEUS-based quantification using VueBox(R) software
Relative Blood Volume (RBV)
Relative/percentage difference of cerebral perfusion by TCEUS-based quantification using VueBox(R) software
Relative Blood Flow (RBF)
Relative/percentage difference of cerebral perfusion by TCEUS-based quantification using VueBox(R) software

Secondary Outcome Measures

Time-To-Peak (TTP)
Relative/percentage difference of cerebral perfusion by TCEUS-based quantification using VueBox(R) software
Time-To-Peak (TTP)
Relative/percentage difference of cerebral perfusion by TCEUS-based quantification using VueBox(R) software
Time-To-Peak (TTP)
Relative/percentage difference of cerebral perfusion by TCEUS-based quantification using VueBox(R) software
Mean-Transit-Time (MTT)
Relative/percentage difference of cerebral perfusion by TCEUS-based quantification using VueBox(R) software
Mean-Transit-Time (MTT)
Relative/percentage difference of cerebral perfusion by TCEUS-based quantification using VueBox(R) software
Mean-Transit-Time (MTT)
Relative/percentage difference of cerebral perfusion by TCEUS-based quantification using VueBox(R) software
Maximum Intensity (MI)
Relative/percentage difference of cerebral perfusion by TCEUS-based quantification using VueBox(R) software
Maximum Intensity (MI)
Relative/percentage difference of cerebral perfusion by TCEUS-based quantification using VueBox(R) software
Maximum Intensity (MI)
Relative/percentage difference of cerebral perfusion by TCEUS-based quantification using VueBox(R) software
Relative Blood Volume (RBV)
Relative/percentage difference of cerebral perfusion by TCEUS-based quantification using VueBox(R) software
Relative Blood Volume (RBV)
Relative/percentage difference of cerebral perfusion by TCEUS-based quantification using VueBox(R) software
Relative Blood Volume (RBV)
Relative/percentage difference of cerebral perfusion by TCEUS-based quantification using VueBox(R) software
Relative Blood Flow (RBF)
Relative/percentage difference of cerebral perfusion by TCEUS-based quantification using VueBox(R) software
Relative Blood Flow (RBF)
Relative/percentage difference of cerebral perfusion by TCEUS-based quantification using VueBox(R) software
Relative Blood Flow (RBF)
Relative/percentage difference of cerebral perfusion by TCEUS-based quantification using VueBox(R) software

Full Information

First Posted
July 4, 2017
Last Updated
September 28, 2021
Sponsor
University of Erlangen-Nürnberg Medical School
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1. Study Identification

Unique Protocol Identification Number
NCT03215628
Brief Title
Quantification of Cerebral Perfusion by Contrast-enhanced Ultrasound During Neonatal Heart Surgery
Acronym
TCEUS
Official Title
Quantifizierung Der Hirnperfusion Während Kinderherzchirurgischer Operationen Durch Transkraniellen Kontrastmittelverstärkten Ultraschall
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
July 4, 2017 (Actual)
Primary Completion Date
June 30, 2021 (Actual)
Study Completion Date
August 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Erlangen-Nürnberg Medical School

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Defects, Congenital
Keywords
CEUS, TCEUS, contrast enhanced ultrasound, perfusion, cerebral perfusion, sulphur hexafluoride, SonoVue

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group A - TCEUS with HLM
Arm Type
Active Comparator
Arm Description
General neonatal cardiac surgery with HLM (art. switch, aortopulmonary shunts)
Arm Title
Group B - TCEUS with HLM
Arm Type
Experimental
Arm Description
Surgery of the aortic arc
Arm Title
Group C - TCEUS without HLM
Arm Type
Active Comparator
Arm Description
Neonatal cardiac surgery without HLM
Intervention Type
Diagnostic Test
Intervention Name(s)
TCEUS
Other Intervention Name(s)
Transcranial contrast-enhanced ultrasound
Intervention Description
Intravenous sulphur hexafluoride microbubbles
Primary Outcome Measure Information:
Title
Time-To-Peak (TTP)
Description
Relative/percentage difference of cerebral perfusion by TCEUS-based quantification using VueBox(R) software
Time Frame
Intraoperative (Directly after start of surgical intervention (T1) vs. Directly before end of intervention (T5))
Title
Mean-Transit-Time (MTT)
Description
Relative/percentage difference of cerebral perfusion by TCEUS-based quantification using VueBox(R) software
Time Frame
Intraoperative (Directly after start of surgical intervention (T1) vs. Directly before end of intervention (T5))
Title
Maximum Intensity (MI)
Description
Relative/percentage difference of cerebral perfusion by TCEUS-based quantification using VueBox(R) software
Time Frame
Intraoperative (Directly after start of surgical intervention (T1) vs. Directly before end of intervention (T5))
Title
Relative Blood Volume (RBV)
Description
Relative/percentage difference of cerebral perfusion by TCEUS-based quantification using VueBox(R) software
Time Frame
Intraoperative (Directly after start of surgical intervention (T1) vs. Directly before end of intervention (T5))
Title
Relative Blood Flow (RBF)
Description
Relative/percentage difference of cerebral perfusion by TCEUS-based quantification using VueBox(R) software
Time Frame
Intraoperative (Directly after start of surgical intervention (T1) vs. Directly before end of intervention (T5))
Secondary Outcome Measure Information:
Title
Time-To-Peak (TTP)
Description
Relative/percentage difference of cerebral perfusion by TCEUS-based quantification using VueBox(R) software
Time Frame
Directly after start of surgical intervention (T1) vs. Directly after full flow of HLM at 37°C (T2)
Title
Time-To-Peak (TTP)
Description
Relative/percentage difference of cerebral perfusion by TCEUS-based quantification using VueBox(R) software
Time Frame
Directly after start of surgical intervention (T1) vs. Directly after full flow of HLM at 25-28°C/hypothermia (T3)
Title
Time-To-Peak (TTP)
Description
Relative/percentage difference of cerebral perfusion by TCEUS-based quantification using VueBox(R) software
Time Frame
Directly after start of surgical intervention (T1) vs. Directly after low flow of HLM at 25-28°C/hypothermia (T4)
Title
Mean-Transit-Time (MTT)
Description
Relative/percentage difference of cerebral perfusion by TCEUS-based quantification using VueBox(R) software
Time Frame
Directly after start of surgical intervention (T1) vs. Directly after full flow of HLM at 37°C (T2)
Title
Mean-Transit-Time (MTT)
Description
Relative/percentage difference of cerebral perfusion by TCEUS-based quantification using VueBox(R) software
Time Frame
Directly after start of surgical intervention (T1) vs. Directly after full flow of HLM at 25-28°C/hypothermia (T3)
Title
Mean-Transit-Time (MTT)
Description
Relative/percentage difference of cerebral perfusion by TCEUS-based quantification using VueBox(R) software
Time Frame
Directly after start of surgical intervention (T1) vs. Directly after low flow of HLM at 25-28°C/hypothermia (T4)
Title
Maximum Intensity (MI)
Description
Relative/percentage difference of cerebral perfusion by TCEUS-based quantification using VueBox(R) software
Time Frame
Directly after start of surgical intervention (T1) vs. Directly after full flow of HLM at 37°C (T2)
Title
Maximum Intensity (MI)
Description
Relative/percentage difference of cerebral perfusion by TCEUS-based quantification using VueBox(R) software
Time Frame
Directly after start of surgical intervention (T1) vs. Directly after full flow of HLM at 25-28°C/hypothermia (T3)
Title
Maximum Intensity (MI)
Description
Relative/percentage difference of cerebral perfusion by TCEUS-based quantification using VueBox(R) software
Time Frame
Directly after start of surgical intervention (T1) vs. Directly after low flow of HLM at 25-28°C/hypothermia (T4)
Title
Relative Blood Volume (RBV)
Description
Relative/percentage difference of cerebral perfusion by TCEUS-based quantification using VueBox(R) software
Time Frame
Directly after start of surgical intervention (T1) vs. Directly after full flow of HLM at 37°C (T2)
Title
Relative Blood Volume (RBV)
Description
Relative/percentage difference of cerebral perfusion by TCEUS-based quantification using VueBox(R) software
Time Frame
Directly after start of surgical intervention (T1) vs. Directly after full flow of HLM at 25-28°C/hypothermia (T3)
Title
Relative Blood Volume (RBV)
Description
Relative/percentage difference of cerebral perfusion by TCEUS-based quantification using VueBox(R) software
Time Frame
Directly after start of surgical intervention (T1) vs. Directly after low flow of HLM at 25-28°C/hypothermia (T4)
Title
Relative Blood Flow (RBF)
Description
Relative/percentage difference of cerebral perfusion by TCEUS-based quantification using VueBox(R) software
Time Frame
Directly after start of surgical intervention (T1) vs. Directly after full flow of HLM at 37°C (T2)
Title
Relative Blood Flow (RBF)
Description
Relative/percentage difference of cerebral perfusion by TCEUS-based quantification using VueBox(R) software
Time Frame
Directly after start of surgical intervention (T1) vs. Directly after full flow of HLM at 25-28°C/hypothermia (T3)
Title
Relative Blood Flow (RBF)
Description
Relative/percentage difference of cerebral perfusion by TCEUS-based quantification using VueBox(R) software
Time Frame
Directly after start of surgical intervention (T1) vs. Directly after low flow of HLM at 25-28°C/hypothermia (T4)

10. Eligibility

Sex
All
Maximum Age & Unit of Time
4 Months
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
André Rüffer, MD
Organizational Affiliation
University Hospital Erlangen, Department of Pediatric Cardiac Surgery
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jörg Jüngert, MD
Organizational Affiliation
University Hospital Erlangen, Department of Pediatrics
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital of Erlangen-Nürnberg, Department of Pediatric Cardiac Surgery
City
Erlangen
ZIP/Postal Code
91054
Country
Germany

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
35380495
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.
Results Reference
derived
PubMed Identifier
34718510
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.
Results Reference
derived

Learn more about this trial

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

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