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Brain Ultrafast Ultrasound Imaging

NCT ID: NCT07299721

Last Updated: 2025-12-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2026-01-01

Study Completion Date

2029-01-01

Brief Summary

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Congenital heart defects affect 1 in 100 births in France, with rising prevalence due to better care. Despite improved survival, 40% of children post-surgery face neurological impairments, and some of them show brain lesions. Causes include heart defects, genetic syndromes, and surgeries. Some heart defects and support systems increase cerebral risks. Monitoring cerebral perfusion is difficult to assess but emerging ultrafast ultrasound offers real-time, non-invasive blood flow insights.

Detailed Description

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Congenital heart defects affect 1 in 100 live births in France. While incidence remains stable, prevalence is rising due to improved medical care, with cases expected to double by 2050. Despite increased survival, neurological comorbidities remain a major concern, with 40% of patients undergoing childhood cardiac surgery experiencing impairments and 73% presenting MRI-detectable brain lesions postoperatively. These injuries result from congenital heart defects, haemodynamic disturbances, genetic syndromes, and neonatal surgeries with extracorporeal circulation.

Some heart defects, such as systemic-to-pulmonary shunts and cyanotic heart diseases, impair cerebral perfusion, increasing the risk of hypoxia and stroke. Mechanical circulatory support systems (e.g. ECMO, cardiopulmonary bypass) also contribute to cerebral risks due to hypoperfusion and clotting complications.

Cerebral autoregulation helps maintain stable perfusion despite blood pressure variations. However, bedside cerebral perfusion monitoring remains challenging leading to reliance on indirect methods like near-infrared spectroscopy (NIRS) and transcranial Doppler (TCD), both with limitations. Ultrafast ultrasound (UFUS) is an emerging non-invasive technique that enables real-time quantification of cerebral blood flow, offering new insights into neonatal cerebral haemodynamics.

Conditions

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CHD - Congenital Heart Disease

Keywords

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Congenital Heart Disease Paediatric Cardiac Imaging Ultrafast ultrasounf

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Patient receiving a transcranial Doppler

Every patient receiving a transcranial Doppler in routine care in our CHD unit of intensive care and anaesthesiology for cardiovascular surgery department

Ultrafast ultrasound (UFUS)

Intervention Type OTHER

Ultrafast ultrasound imaging(UFUS), ultrasound images at a very high rate, using a Verasonics system (ultrasound open platform).

Interventions

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Ultrafast ultrasound (UFUS)

Ultrafast ultrasound imaging(UFUS), ultrasound images at a very high rate, using a Verasonics system (ultrasound open platform).

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Every patient under 2 years old any sex or gender hospitalised in the congenital heart disease unit of the intensive care and anaesthesia for cardiovascular surgery, CHU de Bordeaux.
* Open anterior fontanella
* congenital heart disease
* cardiac shock necessitating mechanical circulatory support.
* Social security affiliation
* Parental or legal guardian's non-opposition

Exclusion Criteria

* Anechoic
* Allergy to echocardiography gel.
Minimum Eligible Age

0 Years

Maximum Eligible Age

2 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Bordeaux

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Haut Lévêque Cardiology Hospital

Pessac, France, France

Site Status

Countries

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France

Central Contacts

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Olivier VILLEMAIN, MD,PhD

Role: CONTACT

Phone: +33 5 24 54 94 79

Email: [email protected]

Facility Contacts

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Olivier VILLEMAIN, MD,PHD

Role: primary

Related Links

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https://pubmed.ncbi.nlm.nih.gov/26472940/

Related Info

Other Identifiers

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CHUBX 2025/28

Identifier Type: -

Identifier Source: org_study_id

CER-BDX 2025-136

Identifier Type: OTHER

Identifier Source: secondary_id