Brain PERfusion Evaluation by Contrast-Enhanced UltraSound

Recruiting

• Conditions: Subarachnoid Hemorrhage; Ischemic Stroke; Cerebrovascular Circulation; Cerebral Hemorrhage; Perfusion
• Interventions: Diagnostic Test: Measuring contrast-enhanced ultrasound perfusion with phase inversion harmonic imaging

• Registration Number: NCT05893407
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

Brief Summary

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.

Detailed 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

Study Timeline

• Study First Submitted: 2023-05-29
• Study First Submitted QC: 2023-05-29
• Study First Posted: 2023-06-07
• Status Verified: 2023-07
• Study Start: 2023-07-21
• Last Update Submitted: 2023-07-23
• Last Update Posted: 2023-07-25
• Primary Completion: 2025-07
• Study Completion: 2025-07

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with acute brain injuries when a contrast ultrasound imaging is requested by the physician	Measuring contrast-enhanced ultrasound perfusion with phase inversion harmonic imaging	Contrast-enhanced ultrasound perfusion imaging (PerCEUS)

Primary Outcome Measures

Name	Time	Method
Evaluation of the heterogeneity of brain perfusion by peak-intensities (PI) measurement	30 minutes after PerCEUS	Comparison between peak-intensities (PI) measured in ROIs in each area by PerCEUS
Evaluation of the heterogeneity of brain perfusion by time-to-peak (TPI) measurement	30 minutes after PerCEUS	Comparison between time-to-peak (TPI) intensities measured in ROIs in each area by PerCEUS

Secondary Outcome Measures

Name	Time	Method
Correlation between PerCEUS parameters and cerebral perfusion as assessed by SjvO2	30 minutes after PerCEUS	Correlations test between TPI/PI and SjvO2
Correlation between PerCEUS parameters and cerebral perfusion as assessed by TCD	30 minutes after PerCEUS	Correlations test between TPI/PI and MFV
Correlation between PerCEUS parameters and cerebral perfusion as assessed by NIRS	30 minutes after PerCEUS	orrelations test between TPI/PI and rSO2
Correlation between PerCEUS parameters and cerebral perfusion as assessed by ICP and MAP	30 minutes after PerCEUS	Correlations test between TPI/PI and ICP/CPP/MAP

Trial Locations

Locations (1)

Lariboisière Hospital; 🇫🇷 Paris, France