Brain PERfusion Evaluation by Contrast-Enhanced UltraSound

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorAssistance Publique - Hôpitaux de Paris

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥18

Intensive care unit admission for acute brain injury

Proven acute brain injury by CT and/or MRI

Requiring a contrast ultrasound imaging

Disqualifiers

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 population

Patients hospitalized in neurosurgical intensive care in Lariboisière Hospital, Paris, with acute brain injuries

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • 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.

Treatment groups

60 Participants
are divided into 1 treatment group
Group A: Patients with acute brain injuries when a contrast ultrasound imaging is requested by the physician1 intervention

Trial outcomes

Primary outcomes

1

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

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

Time frame
30 minutes after PerCEUS
2

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

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

Time frame
30 minutes after PerCEUS

Secondary outcomes

1

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

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

Time frame
30 minutes after PerCEUS
2

Correlation between PerCEUS parameters and cerebral perfusion as assessed by TCD

Correlations test between TPI/PI and MFV

Time frame
30 minutes after PerCEUS
3

Correlation between PerCEUS parameters and cerebral perfusion as assessed by NIRS

orrelations test between TPI/PI and rSO2

Time frame
30 minutes after PerCEUS
4

Correlation between PerCEUS parameters and cerebral perfusion as assessed by SjvO2

Correlations test between TPI/PI and SjvO2

Time frame
30 minutes after PerCEUS

Other outcomes

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