Prospective Study Comparing Ultrasound Cerebral Perfusion Imaging With Routine Perfusion CT in ICU or CCU Patients

What this Trial Is About

Researchers are studying patients admitted to intensive care units with neurocritical conditions such as subarachnoid hemorrhage and cerebral ischemia. The study aims to evaluate the accuracy of cerebral perfusion measurements obtained using the SYLVER ultrasound imaging system compared to routine perfusion CT scans. This research is important because early detection of delayed cerebral ischemia, a common and serious complication, can guide treatment and improve patient outcomes. Participants admitted to the ICU or CCU with an indication for at least one perfusion CT (CTP) scan will be enrolled. The study involves using a contrast-enhanced ultrasound agent with the SYLVER device to measure cerebral blood flow and perfusion non-invasively at the bedside. Assessments occur during hospitalization with up to six visits, including a screening visit and up to five follow-up visits within 21 days. These visits include clinical exams, transcranial Doppler (TCD), perfusion CT and CT angiography (CTA), and SYLVER ultrasound scans. Participants will undergo multiple assessments such as demographic and medical history collection, clinical exams, and imaging tests including CTP, CTA, TCD, and SYLVER ultrasound scans. Researchers will collect data on cerebral perfusion, vascular anatomy, blood flow velocities, and any adverse events related to the SYLVER device. The primary outcome is the agreement between SYLVER measurements and CT perfusion data over multiple visits within 21 days. Safety and diagnostic performance will be monitored throughout the study duration.

Comparison of Ultrasound Cerebral Perfusion Imaging With Routine Perfusion CT