PerCEUS: Brain PERfusion Evaluation by Contrast-Enhanced UltraSound

Sponsor
Assistance Publique - Hôpitaux de Paris (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05893407
Collaborator
(none)
60
1
24
2.5

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Measuring contrast-enhanced ultrasound perfusion with phase inversion harmonic imaging

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 Design

Study Type:
Observational
Anticipated Enrollment :
60 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Quantification of Cerebral Perfusion at the Patient's Bedside When Performing Contrast-enhanced Ultrasound in Neurointensive Care Patients
Anticipated Study Start Date :
Jul 1, 2023
Anticipated Primary Completion Date :
Jul 1, 2025
Anticipated Study Completion Date :
Jul 1, 2025

Arms and Interventions

Arm Intervention/Treatment
Patients with acute brain injuries when a contrast ultrasound imaging is requested by the physician

Contrast-enhanced ultrasound perfusion imaging (PerCEUS)

Diagnostic Test: Measuring contrast-enhanced ultrasound perfusion with phase inversion harmonic imaging
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.

Outcome Measures

Primary Outcome Measures

  1. 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

  2. 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

Secondary Outcome Measures

  1. 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

  2. Correlation between PerCEUS parameters and cerebral perfusion as assessed by TCD [30 minutes after PerCEUS]

    Correlations test between TPI/PI and MFV

  3. Correlation between PerCEUS parameters and cerebral perfusion as assessed by NIRS [30 minutes after PerCEUS]

    orrelations test between TPI/PI and rSO2

  4. Correlation between PerCEUS parameters and cerebral perfusion as assessed by SjvO2 [30 minutes after PerCEUS]

    Correlations test between TPI/PI and SjvO2

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Lariboisière Hospital Paris France 75010

Sponsors and Collaborators

  • Assistance Publique - Hôpitaux de Paris

Investigators

  • Principal Investigator: Romain BARTHELEMY, MD, AP-HP Lariboisière Hospital, Department of Anaesthesia and Intensive Care

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT05893407
Other Study ID Numbers:
  • APHP230489
First Posted:
Jun 7, 2023
Last Update Posted:
Jun 7, 2023
Last Verified:
May 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Assistance Publique - Hôpitaux de Paris
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 7, 2023