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

NCT03215628 | Completed

• 1 other identifier: 20_17B
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Defects, Congenital

Keywords

CEUS; TCEUS; contrast enhanced ultrasound; perfusion; cerebral perfusion; sulphur hexafluoride; SonoVue

Outcome Measures

Primary Outcomes (5)

• 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))

• 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))

• 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))

• 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))

• 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 Outcomes (15)

• Time-To-Peak (TTP)

  Directly after start of surgical intervention (T1) vs. Directly after full flow of HLM at 37°C (T2)

• Time-To-Peak (TTP)

  Directly after start of surgical intervention (T1) vs. Directly after full flow of HLM at 25-28°C/hypothermia (T3)

• 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 full flow of HLM at 37°C (T2)

• Mean-Transit-Time (MTT)

  Directly after start of surgical intervention (T1) vs. Directly after full flow of HLM at 25-28°C/hypothermia (T3)

Study Arms (3)

Group A - TCEUS with HLM

ACTIVE COMPARATOR

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

Diagnostic Test: TCEUS

Group B - TCEUS with HLM

EXPERIMENTAL

Surgery of the aortic arc

Diagnostic Test: TCEUS

Group C - TCEUS without HLM

ACTIVE COMPARATOR

Neonatal cardiac surgery without HLM

Diagnostic Test: TCEUS

Interventions

TCEUS DIAGNOSTIC_TEST

Intravenous sulphur hexafluoride microbubbles

Also known as: Transcranial contrast-enhanced ultrasound

Group A - TCEUS with HLM; Group B - TCEUS with HLM; Group C - TCEUS without HLM

Eligibility Criteria

• Age: Up to 4 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Erlangen-Nürnberg Medical School: lead

Study Sites (1)

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

Erlangen, 91054, Germany

Location

Related Publications (2)

• 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.

  PMID: 35380495 DERIVED

• 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.

  PMID: 34718510 DERIVED

MeSH Terms

Conditions

Heart Defects, Congenital

Condition Hierarchy (Ancestors)

Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• André Rüffer, MD

  University Hospital Erlangen, Department of Pediatric Cardiac Surgery

  PRINCIPAL INVESTIGATOR

• Jörg Jüngert, MD

  University Hospital Erlangen, Department of Pediatrics

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 4, 2017
• First Posted: July 12, 2017
• Study Start: July 4, 2017
• Primary Completion: June 30, 2021
• Study Completion: August 30, 2021
• Last Updated: September 29, 2021

Record last verified: 2020-11

Locations

DE (1)