Brain Ultrafast Ultrasound Imaging

NCT07299721 | Not Yet Recruiting

• 2 other identifiers: CHUBX 2025/28CER-BDX 2025-136
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

CHD - Congenital Heart Disease

Keywords

Congenital Heart Disease; Paediatric; Cardiac Imaging; Ultrafast ultrasounf

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (13)

• 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

Study Arms (1)

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)

Interventions

Ultrafast ultrasound (UFUS) OTHER

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

Patient receiving a transcranial Doppler

Eligibility Criteria

• Age: 0 Years - 2 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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.

You may qualify if:

• 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

You may not qualify if:

• Anechoic
• Allergy to echocardiography gel.

Sponsors & Collaborators

• University Hospital, Bordeaux: lead

Study Sites (1)

Haut Lévêque Cardiology Hospital

Pessac, France, 33604, France

Location

Related Links

• Related Info

MeSH Terms

Conditions

Heart Defects, Congenital

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Olivier VILLEMAIN, MD,PhD

CONTACT

+33 5 24 54 94 79; olivier.villemain@chu-bordeaux.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 19, 2025
• First Posted: December 23, 2025
• Study Start: January 1, 2026
• Primary Completion: January 1, 2026
• Study Completion (Estimated): January 1, 2029
• Last Updated: December 23, 2025

Record last verified: 2025-12

Locations

FR (1)