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Clinical Trials/NCT05893407
NCT05893407
Recruiting
N/A

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

Assistance Publique - Hôpitaux de Paris1 site in 1 country60 target enrollmentJuly 21, 2023

Overview

Phase
N/A
Intervention
Not specified
Conditions
Cerebral Hemorrhage
Sponsor
Assistance Publique - Hôpitaux de Paris
Enrollment
60
Locations
1
Primary Endpoint
Evaluation of the heterogeneity of brain perfusion by peak-intensities (PI) measurement
Status
Recruiting
Last Updated
10 months ago

Overview

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

Registry
clinicaltrials.gov
Start Date
July 21, 2023
End Date
July 2025
Last Updated
10 months ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • 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

Outcomes

Primary Outcomes

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

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

Secondary Outcomes

  • Correlation between PerCEUS parameters and cerebral perfusion as assessed by SjvO2(30 minutes after PerCEUS)
  • Correlation between PerCEUS parameters and cerebral perfusion as assessed by TCD(30 minutes after PerCEUS)
  • Correlation between PerCEUS parameters and cerebral perfusion as assessed by NIRS(30 minutes after PerCEUS)
  • Correlation between PerCEUS parameters and cerebral perfusion as assessed by ICP and MAP(30 minutes after PerCEUS)

Study Sites (1)

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