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NCT Number: NCT05893407

Brain PERfusion Evaluation by Contrast-Enhanced UltraSound

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.

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Key information

Conditions

Cerebral Hemorrhage Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Circulation Cerebrovascular Disorders Hemorrhage Intracranial Hemorrhages Ischemic Stroke Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Perfusion Stroke Subarachnoid Hemorrhage Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Measuring contrast-enhanced ultrasound perfusion with phase inversion harmonic imaging

Diagnostic Test

Contrast-enhanced ultrasound perfusion imaging (PerCEUS) will be performed by a dedicated study team. The transcranial color duplex sonography will be performed with a 1-5 MHz dynamic sector array (S5-1) from a Philips Epiq 7 ultrasound machine (Philips Healthcare, Andover, MA). The field-of-view will be set to an imaging depth of 150 mm in a sector angle of 90°. The imaging plane will be then tilted to the diencephalic, in which the frontal horns of the side ventricles and the third ventricle serve as landmarks and where the anterior and posterior middle cerebral artery (MCA) territory and the basal ganglia (BG) as region of interest could be identified without artefacts from major vessels. High mechanical index bolus imaging will be performed from the sanest side of the head. Data acquisition of 45 seconds will be recorded immediately after the beginning of the contrast ultrasound imaging, using a mechanical index (MI) setting of 1.1 and a frame rate of 33 Hz.

Primary outcomes

  1. Evaluation of the heterogeneity of brain perfusion by time-to-peak (TPI) measurement

    Time frame: 30 minutes after PerCEUS

    Comparison between time-to-peak (TPI) intensities measured in ROIs in each area by PerCEUS

  2. Evaluation of the heterogeneity of brain perfusion by peak-intensities (PI) measurement

    Time frame: 30 minutes after PerCEUS

    Comparison between peak-intensities (PI) measured in ROIs in each area by PerCEUS

Secondary outcomes

  1. Correlation between PerCEUS parameters and cerebral perfusion as assessed by ICP and MAP

    Time frame: 30 minutes after PerCEUS

    Correlations test between TPI/PI and ICP/CPP/MAP

  2. Correlation between PerCEUS parameters and cerebral perfusion as assessed by TCD

    Time frame: 30 minutes after PerCEUS

    Correlations test between TPI/PI and MFV

  3. Correlation between PerCEUS parameters and cerebral perfusion as assessed by NIRS

    Time frame: 30 minutes after PerCEUS

    orrelations test between TPI/PI and rSO2

  4. Correlation between PerCEUS parameters and cerebral perfusion as assessed by SjvO2

    Time frame: 30 minutes after PerCEUS

    Correlations test between TPI/PI and SjvO2

Study contacts

Contact information is provided by the study sponsor or research team.

Benjamin Glenn CHOUSTERMAN, MD PhD

CONTACT

[email protected]

+33 (0)1 49 95 85 18

Romain BARTHELEMY, MD

CONTACT

[email protected]

+33 (0)1 49 95 85 15

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Official study title

Quantification of Cerebral Perfusion at the Patient's Bedside When Performing Contrast-enhanced Ultrasound in Neurointensive Care Patients

Acronym: PerCEUS

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Jun 7, 2023
Registry last updated
Jun 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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