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Completed

NCT Number: NCT03215628

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

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.

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Key information

Conditions

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

Age range

Up to 4 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Erlangen, 91054, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

TCEUS

Diagnostic Test

Intravenous sulphur hexafluoride microbubbles

Other names: Transcranial contrast-enhanced ultrasound

Primary outcomes

  1. Time-To-Peak (TTP)

    Time frame: 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)

    Time frame: 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)

    Time frame: 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)

    Time frame: 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)

    Time frame: 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 outcomes

  1. Time-To-Peak (TTP)

    Time frame: 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)

    Time frame: 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)

    Time frame: 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)

    Time frame: 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)

    Time frame: 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)

    Time frame: 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)

    Time frame: 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)

    Time frame: 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)

    Time frame: 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)

    Time frame: 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)

    Time frame: 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)

    Time frame: 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)

    Time frame: 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)

    Time frame: 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)

    Time frame: 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

Sponsors and collaborators

Lead sponsor

University of Erlangen-Nürnberg Medical School

Other

Registry information

Official study title

Quantifizierung Der Hirnperfusion Während Kinderherzchirurgischer Operationen Durch Transkraniellen Kontrastmittelverstärkten Ultraschall

Acronym: TCEUS

Important dates

Study start
2017
Primary completion
2021
Study completion
2021
First posted
Jul 12, 2017
Registry last updated
Sep 29, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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