Trials / Completed
CompletedNCT03215628
Quantification of Cerebral Perfusion by Contrast-enhanced Ultrasound During Neonatal Heart Surgery
Quantifizierung Der Hirnperfusion Während Kinderherzchirurgischer Operationen Durch Transkraniellen Kontrastmittelverstärkten Ultraschall
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 12 (actual)
- Sponsor
- University of Erlangen-Nürnberg Medical School · Academic / Other
- Sex
- All
- Age
- 4 Months
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DIAGNOSTIC_TEST | TCEUS | Intravenous sulphur hexafluoride microbubbles |
Timeline
- Start date
- 2017-07-04
- Primary completion
- 2021-06-30
- Completion
- 2021-08-30
- First posted
- 2017-07-12
- Last updated
- 2021-09-29
Locations
1 site across 1 country: Germany
Source: ClinicalTrials.gov record NCT03215628. Inclusion in this directory is not an endorsement.