Brain PERfusion Evaluation by Contrast-Enhanced UltraSound

Status Recruiting

Clinical Trial 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.

Clinical Trial 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 Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05893407
Study type	Observational
Source	Assistance Publique - Hôpitaux de Paris
Contact	Romain BARTHELEMY, MD
Phone	+33 (0)1 49 95 85 15
Email	romain.barthelemy@aphp.fr
Status	Recruiting
Phase
Start date	July 21, 2023
Completion date	July 2025

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Brain PERfusion Evaluation by Contrast-Enhanced UltraSound — PerCEUS

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms