Clinical trial NCT05893407: Brain PERfusion Evaluation by Contrast-Enhanced UltraSound
Official title: Quantification of Cerebral Perfusion At the Patient's Bedside When Performing Contrast-enhanced Ultrasound in Neurointensive Care Patients
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cerebral Hemorrhage
Subarachnoid Hemorrhage
Ischemic Stroke
Cerebrovascular Circulation
Perfusion
Keywords: Brain perfusion
Cerebral blood flow
Diagnostic imaging
Ultrasonography Doppler
Doppler ultrasound
Transcranial Doppler
Contrast enhanced ultrasound
Contrast-enhanced ultrasonography
Contrast ultrasound
Ultrasound perfusion imaging
Ultrasound contrast agent
Intra-cranial pressure
Intracerebral hematoma
Neurocritical care
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2023-06-07
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients hospitalized in neurosurgical intensive care in Lariboisière Hospital, Paris, with acute brain injuries

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

Eligibility criteria: 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

Primary outcomes:
measure: Evaluation of the heterogeneity of brain perfusion by time-to-peak (TPI) measurement
timeFrame: 30 minutes after PerCEUS
measure: Evaluation of the heterogeneity of brain perfusion by peak-intensities (PI) measurement
timeFrame: 30 minutes after PerCEUS
Secondary outcomes:
measure: Correlation between PerCEUS parameters and cerebral perfusion as assessed by ICP and MAP
timeFrame: 30 minutes after PerCEUS
measure: Correlation between PerCEUS parameters and cerebral perfusion as assessed by TCD
timeFrame: 30 minutes after PerCEUS
measure: Correlation between PerCEUS parameters and cerebral perfusion as assessed by NIRS
timeFrame: 30 minutes after PerCEUS
measure: Correlation between PerCEUS parameters and cerebral perfusion as assessed by SjvO2
timeFrame: 30 minutes after PerCEUS
Other outcomes:
Locations:
city: Paris
country: France
facility: Lariboisière Hospital
Study officials:
affiliation: AP-HP Lariboisière Hospital, Department of Anaesthesia and Intensive Care
name: Romain BARTHELEMY, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Eyding J, Krogias C, Wilkening W, Postert T. Detection of cerebral perfusion abnormalities in acute stroke using phase inversion harmonic imaging (PIHI): preliminary results. J Neurol Neurosurg Psychiatry. 2004 Jun;75(6):926-9. doi: 10.1136/jnnp.2003.026195.
citation: Eyding J, Fung C, Niesen WD, Krogias C. Twenty Years of Cerebral Ultrasound Perfusion Imaging-Is the Best yet to Come? J Clin Med. 2020 Mar 17;9(3):816. doi: 10.3390/jcm9030816.
citation: Vinke EJ, Kortenbout AJ, Eyding J, Slump CH, van der Hoeven JG, de Korte CL, Hoedemaekers CWE. Potential of Contrast-Enhanced Ultrasound as a Bedside Monitoring Technique in Cerebral Perfusion: a Systematic Review. Ultrasound Med Biol. 2017 Dec;43(12):2751-2757. doi: 10.1016/j.ultrasmedbio.2017.08.935. Epub 2017 Sep 28.
citation: Fung C, Heiland DH, Reitmeir R, Niesen WD, Raabe A, Eyding J, Schnell O, Rolz R, Z Graggen WJ, Beck J. Ultrasound Perfusion Imaging for the Detection of Cerebral Hypoperfusion After Aneurysmal Subarachnoid Hemorrhage. Neurocrit Care. 2022 Aug;37(1):149-159. doi: 10.1007/s12028-022-01460-z. Epub 2022 Feb 24.
citation: Bilotta F, Robba C, Santoro A, Delfini R, Rosa G, Agati L. Contrast-Enhanced Ultrasound Imaging in Detection of Changes in Cerebral Perfusion. Ultrasound Med Biol. 2016 Nov;42(11):2708-2716. doi: 10.1016/j.ultrasmedbio.2016.06.007. Epub 2016 Jul 27.