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IPASS


Title Prospective evaluation of non-invasive intracranial pressure monitoring
Therapeutic Area Intracranial Pressure
Principal Investigator Joshua Kornbluth, MD
Min Age 6 Years
Gender Both
Contact Lindsey Soll
617 636-7620

Overview

Patients who are admitted to the Tufts Medical Center ICU or PICU and are deemed to require placement of an intracranial pressure (ICP) monitor will be asked to enroll in our study. Patients agreeing will undergo the routine placement of an ICP monitor followed by placement of the study device; a non-invasive extracranial device (I PASS - Intracranial Pressure Assessment and Screening System, Vivonics, INC) containing near infrared probes placed on the ear, forehead and finger. The data will be recorded from IPASS as the routine ICP is recorded. Patients vital signs including heart rate, blood pressure, and SpO2 will also be routinely recorded. Once the patient is felt to no longer require the ICP monitor and it is removed, the IPASS device will also be removed.

Study Details

Inclusion Criteria

  • Patients admitted to the Tufts Medical Center ICU or PICU
  • Clinically deemed to require placement of an ICP monitor
  • Patients having had a head CT or MRI

Exclusion Criteria

  • Patients who have uncorrected coagulopathy (a bleeding disorder where the blood is unable to form clots)
  • Patients who cannot tolerate placement of an ICP monitor

Study Requirements

Subjects will undergo routine placement of an ICP monitor followed by the placement of the non-invasive IPASS device. Monitoring will continue until the patient no longer requires ICP monitoring as determined by a qualified physician.