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

• Sponsor: University of Erlangen-Nürnberg Medical School (Other)
• Overall Status: Completed
• CT.gov ID: NCT03215628
• Collaborator: (none)
• Enrollment: 12
• Location: 1
• Arms: 3
• Actual Duration (Months): 49.9
• Patients Per Site Per Month: 0.2

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Heart Defects, Congenital	Diagnostic Test: TCEUS	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 12 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: Quantifizierung Der Hirnperfusion Während Kinderherzchirurgischer Operationen Durch Transkraniellen Kontrastmittelverstärkten Ultraschall
• Actual Study Start Date: Jul 4, 2017
• Actual Primary Completion Date: Jun 30, 2021
• Actual Study Completion Date: Aug 30, 2021

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Group A - TCEUS with HLM General neonatal cardiac surgery with HLM (art. switch, aortopulmonary shunts)	Diagnostic Test: TCEUS; Intravenous sulphur hexafluoride microbubbles; Other Names: Transcranial contrast-enhanced ultrasound
Experimental: Group B - TCEUS with HLM Surgery of the aortic arc	Diagnostic Test: TCEUS; Intravenous sulphur hexafluoride microbubbles; Other Names: Transcranial contrast-enhanced ultrasound
Active Comparator: Group C - TCEUS without HLM Neonatal cardiac surgery without HLM	Diagnostic Test: TCEUS; Intravenous sulphur hexafluoride microbubbles; Other Names: Transcranial contrast-enhanced ultrasound

Outcome Measures

Primary Outcome Measures

1. Time-To-Peak (TTP) [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

2. Mean-Transit-Time (MTT) [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

3. Maximum Intensity (MI) [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

4. Relative Blood Volume (RBV) [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

5. Relative Blood Flow (RBF) [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 Outcome Measures

1. Time-To-Peak (TTP) [Directly after start of surgical intervention (T1) vs. Directly after full flow of HLM at 37°C (T2)]

   Relative/percentage difference of cerebral perfusion by TCEUS-based quantification using VueBox(R) software

2. Time-To-Peak (TTP) [Directly after start of surgical intervention (T1) vs. Directly after full flow of HLM at 25-28°C/hypothermia (T3)]

   Relative/percentage difference of cerebral perfusion by TCEUS-based quantification using VueBox(R) software

3. Time-To-Peak (TTP) [Directly after start of surgical intervention (T1) vs. Directly after low flow of HLM at 25-28°C/hypothermia (T4)]

   Relative/percentage difference of cerebral perfusion by TCEUS-based quantification using VueBox(R) software

4. Mean-Transit-Time (MTT) [Directly after start of surgical intervention (T1) vs. Directly after full flow of HLM at 37°C (T2)]

   Relative/percentage difference of cerebral perfusion by TCEUS-based quantification using VueBox(R) software

5. Mean-Transit-Time (MTT) [Directly after start of surgical intervention (T1) vs. Directly after full flow of HLM at 25-28°C/hypothermia (T3)]

   Relative/percentage difference of cerebral perfusion by TCEUS-based quantification using VueBox(R) software

6. Mean-Transit-Time (MTT) [Directly after start of surgical intervention (T1) vs. Directly after low flow of HLM at 25-28°C/hypothermia (T4)]

   Relative/percentage difference of cerebral perfusion by TCEUS-based quantification using VueBox(R) software

7. Maximum Intensity (MI) [Directly after start of surgical intervention (T1) vs. Directly after full flow of HLM at 37°C (T2)]

   Relative/percentage difference of cerebral perfusion by TCEUS-based quantification using VueBox(R) software

8. Maximum Intensity (MI) [Directly after start of surgical intervention (T1) vs. Directly after full flow of HLM at 25-28°C/hypothermia (T3)]

   Relative/percentage difference of cerebral perfusion by TCEUS-based quantification using VueBox(R) software

9. Maximum Intensity (MI) [Directly after start of surgical intervention (T1) vs. Directly after low flow of HLM at 25-28°C/hypothermia (T4)]

   Relative/percentage difference of cerebral perfusion by TCEUS-based quantification using VueBox(R) software

10. Relative Blood Volume (RBV) [Directly after start of surgical intervention (T1) vs. Directly after full flow of HLM at 37°C (T2)]

    Relative/percentage difference of cerebral perfusion by TCEUS-based quantification using VueBox(R) software

11. Relative Blood Volume (RBV) [Directly after start of surgical intervention (T1) vs. Directly after full flow of HLM at 25-28°C/hypothermia (T3)]

    Relative/percentage difference of cerebral perfusion by TCEUS-based quantification using VueBox(R) software

12. 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/percentage difference of cerebral perfusion by TCEUS-based quantification using VueBox(R) software

13. Relative Blood Flow (RBF) [Directly after start of surgical intervention (T1) vs. Directly after full flow of HLM at 37°C (T2)]

    Relative/percentage difference of cerebral perfusion by TCEUS-based quantification using VueBox(R) software

14. Relative Blood Flow (RBF) [Directly after start of surgical intervention (T1) vs. Directly after full flow of HLM at 25-28°C/hypothermia (T3)]

    Relative/percentage difference of cerebral perfusion by TCEUS-based quantification using VueBox(R) software

15. Relative Blood Flow (RBF) [Directly after start of surgical intervention (T1) vs. Directly after low flow of HLM at 25-28°C/hypothermia (T4)]

    Relative/percentage difference of cerebral perfusion by TCEUS-based quantification using VueBox(R) software

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A to 4 Months
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Hospital of Erlangen-Nürnberg, Department of Pediatric Cardiac Surgery	Erlangen		Germany	91054

Sponsors and Collaborators

• University of Erlangen-Nürnberg Medical School

Investigators

• Principal Investigator: André Rüffer, MD, University Hospital Erlangen, Department of Pediatric Cardiac Surgery
• Principal Investigator: Jörg Jüngert, MD, University Hospital Erlangen, Department of Pediatrics

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University of Erlangen-Nürnberg Medical School
• ClinicalTrials.gov Identifier: NCT03215628
• Other Study ID Numbers: 20_17B
• First Posted: Jul 12, 2017
• Last Update Posted: Sep 29, 2021
• Last Verified: Nov 1, 2020

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• 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
• Keywords provided by University of Erlangen-Nürnberg Medical School: CEUS; TCEUS; contrast enhanced ultrasound; perfusion; cerebral perfusion; sulphur hexafluoride; SonoVue
• Additional relevant MeSH terms: Heart Defects, Congenital; Congenital Abnormalities

Study Results

No Results Posted as of Sep 29, 2021