Brain PERfusion Evaluation by Contrast-Enhanced UltraSound (PerCEUS)

Assistance Publique - Hôpitaux de Paris

Status: Enrolling

Conditions: Subarachnoid Hemorrhage; Cerebral Hemorrhage; Ischemic Stroke; Perfusion; Cerebrovascular Circulation

Treatments: Diagnostic Test: Measuring contrast-enhanced ultrasound perfusion with phase inversion harmonic imaging

Study type: Observational

Funder types: Other

Identifiers

NCT05893407

2023-A00939-36 (Other Identifier)

APHP230489

Details and patient eligibility

About

The objective of the study is to assess brain tissue perfusion by contrast-enhanced ultrasound perfusion imaging (PerCEUS) in acute brain injuries. More precisely, it aims :

• to evaluate the heterogeneity of brain perfusion and thus diagnose brain tissue hypoperfusion with contrast-enhanced ultrasound.
• to correlate contrast-enhanced ultrasound with perfusion measurements by usual multimodal monitoring.

Full description

The main aim is to evaluate the heterogeneity of brain perfusion, thus diagnosing brain tissue hypoperfusion with PerCEUS, then to correlate it with the usual multimodal monitoring.

Earlier after hospitalization in neurointensive care, when the study physician needs to realize a contrast ultrasound imaging and without delaying any emergency procedure, a PerCEUS will be performed in patients with an acute brain injury. After acquisition, data from PerCEUS will be transferred to an external evaluation unit and analysed offline, using commercially available software Qlab (Philips ®). According to the localization of acute brain injuries with magnetic resonance imaging (MRI) and/or computed tomography (CT), several regions-of-interest (ROI, at least three in each area) will be chosen :

• Area 1 : in the core of the lesion (supposed non perfused)
• Area 2 : just next to the lesion (supposed hypoperfused)
• Area 3 : in the saner hemisphere, symmetrically to area 2 each time it's possible (supposed well-perfused).

Every parameters of multimodal monitoring used at the moment of PerCEUS will be relieved :

• intracranial pressure (ICP), cerebral perfusion pressure (CPP), mean arterial pressure (MAP)
• mean flow velocity (MFV) by transcranial doppler (TCD)
• regional cerebral oxygen saturation (rSO2) by Near infrared spectroscopy (NIRS)
• jugular venous oximetry (SjvO2).

The actual PerCEUS measurement takes place at the bedside, is performed by the study physician, and takes about 5 minutes.

The trial duration per patient is 30 minutes, ending after 25 minutes of oversight

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age ≥18
• Intensive care unit admission for acute brain injury
• Proven acute brain injury by CT and/or MRI
• Requiring a contrast ultrasound imaging
• Informed consent of patient or relative

Exclusion criteria

• Pregnancy
• Not sufficient temporal window
• Contraindications to Sonovue ® : acute coronary syndromes, severe ischemic heart disease (requiring revascularization), pulmonary arterial hypertension > 90 mmHg, right-left shunt, ARDS, dobutamine's use, known allergy or adverse reaction to Sonovue®
• Patient on State Medical Assistance

Trial design

60 participants in 1 patient group

Patients with acute brain injuries when a contrast ultrasound imaging is requested by the physician

Description:

Contrast-enhanced ultrasound perfusion imaging (PerCEUS)

Treatment:

Diagnostic Test: Measuring contrast-enhanced ultrasound perfusion with phase inversion harmonic imaging