Brain Ultrafast Ultrasound Imaging (Brain Ultrafas)

Brain Ultrafast Ultrasound Imaging: Application in Pediatric Cardiology: Brain Ultrafast

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.

Study Overview

• Status: Not yet recruiting
• Conditions: CHD - Congenital Heart Disease
• Intervention / Treatment: Other: Ultrafast ultrasound (UFUS)

Detailed Description

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.

• Study Type: Observational
• Enrollment (Estimated): 300

Contacts and Locations

• Study Contact: Name: Olivier VILLEMAIN, MD,PHD; Phone Number: +33 +33 5 24 54 94 79; Email: olivier.villemain@chu-bordeaux.fr

Study Locations

• France
  • France
    • Pessac, France, France, 33604
      • Haut Lévêque Cardiology Hospital
      • Contact: Olivier VILLEMAIN, MD,PHD; Phone Number: +33 +33 5 24 54 94 79; Email: olivier.villemain@chu-bordeaux.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Every patient, under two years old, receiving a transcranial Doppler in routine care in our CHD unit of intensive care and anaesthesiology for cardiovascular surgery department.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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	Other: Ultrafast ultrasound (UFUS); Ultrafast ultrasound imaging(UFUS), ultrasound images at a very high rate, using a Verasonics system (ultrasound open platform).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cerebral blood volume variation	Depending on stage of medico-surgical treatment	at baseline
Cerebral blood volume variation	Depending on hemodynamic or ventilatory situation, and exposure to vasoactive or neuroactive drugs.	at baseline

Secondary Outcome Measures

Outcome Measure	Time Frame
Evolution of Arterial blood pressure	at baseline
Evolution of central venous blood pressure	at baseline
Evolution of left atrial pressure	at baseline
Evolution of SpO2	at baseline
Evolution of SaO2	at baseline
Evolution of SvO2	at baseline
Evolution of PaCO2	at baseline
Evolution of PaO2	at baseline
Evolution of Hemoglobinemia	at baseline
Inotropic drugs dosages	at baseline
Vasopressive drugs dosages	at baseline
Sedation dosages	at baseline
Analgesia dosages	at baseline

Collaborators and Investigators

• Sponsor: University Hospital, Bordeaux

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2026
• Primary Completion (Estimated): January 1, 2026
• Study Completion (Estimated): January 1, 2029

Study Registration Dates

• First Submitted: November 19, 2025
• First Submitted That Met QC Criteria: December 9, 2025
• First Posted (Actual): December 23, 2025

Study Record Updates

• Last Update Posted (Actual): December 23, 2025
• Last Update Submitted That Met QC Criteria: December 9, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Congenital Heart Disease; Paediatric; Cardiac Imaging; Ultrafast ultrasounf
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Cardiovascular Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Heart Defects, Congenital
• Other Study ID Numbers: CHUBX 2025/28; CER-BDX 2025-136 (Other Identifier: Comité d'Etique - Centre Ethique et Recherche en Santé de Bordeaux)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No