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NIRS


Title A pilot study to assess non-invasive near-infrared spectroscopy measurements of Coherent Hemodynamics Spectroscopy for the assessment of cerebral autoregulation and blood flow
Therapeutic Area Intracranial Pressure
Principal Investigator Joshua Kornbluth, MD
Min Age 18 Years
Gender All
Contact Emma Jost-Price
617-636-7606
ejostprice@tuftsmedicalcenter.org

Overview

This study is being done to find out if an external and painless method of measuring and monitoring the health of blood vessels within the head and the blood that flows in them is possible. This may be useful to clinicians as changes in cerebral blood flow are a frequent complication of neurological and neurosurgical disease and frequently need to be treated and monitored. Our goal is to show that this simple external monitor can improve the information that standard monitors provide, including surgically-implanted monitors. The way in which intracranial pressure (ICP) is monitored is by using a catheter inserted through the skull into the brain though a small incision made under local anesthesia at the bedside in the Intensive Care Unit (ICU) where you are staying. In contrast, our method of monitoring uses a small optical probe taped temporarily to the skin of your forehead. By comparing the data we will get from this study monitor to the standard monitors you already have, we hope to prove that this technology can be used to replace invasive procedures for these measurements.

The Near Infrared Spectroscopy (NIRS) device which will be taped to your forehead (ISS OxiplexTS), uses low energy light to measure oxygen levels in your blood.  It is similar to the probe that is placed on your finger to measure your oxygen levels.  The ISS OxiplexTX has been approved by the FDA to obtain NIRS measurements, but it has not been used in this way before.

Study Details

Inclusion Criteria

  • Subjects who have Subarachnoid hemorrhage (SAH)
  • Subjects who demonstrate clinical stability defined as a stable neurologic exam for >24 hours
  • hemodynamically stable (it means that the force at which the heart pumps blood is  without evidence of cardiac ischemia

Exclusion Criteria

  • Pregnant or breastfeeding women
  • Expectation for cranial surgery within 24 hours
  • Severe facial or scalp trauma

Study Requirements

Device setup and baseline characteristics recorded within 24 hours of enrollment. Duration of study will be 21 days. We anticipate 2 separate 30-minute sessions 3 days per week for up to 3 weeks for a maximum total of 18 monitoring sessions. As part of this study, we may refer to laboratory values of blood collected that day for your routine care. We will not be collecting blood specifically for this study.