The Use of Near Infrared Spectroscopy (NIRS) to Estimate Intracranial Pressure (ICP)

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2016 by University of Virginia
Information provided by (Responsible Party):
Bhiken I. Naik, MD, University of Virginia Identifier:
First received: April 25, 2013
Last updated: May 10, 2016
Last verified: May 2016
The aim of this study is to determine whether we can predict the intracranial pressure using near infra-red spectroscopy

Intracranial Hypertension

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Use of Near Infrared Spectroscopy (NIRS) to Estimate Intracranial Pressure (ICP)

Resource links provided by NLM:

Further study details as provided by University of Virginia:

Primary Outcome Measures:
  • Intracranial elastance [ Time Frame: Participants will be followed while an arterial line and intracranial pressure monitor is present duing the ICU admission. This is expected to be an average of 5 days. ] [ Designated as safety issue: No ]
    Intracranial elastance (δP/δV)will be measured by dividing the pulse pressure of an invasive arterial blood pressure by the amplitude of high frequency oscillations in the near infrared (NIR) absorbance waveforms.

Estimated Enrollment: 59
Study Start Date: June 2014
Estimated Study Completion Date: June 2016
Estimated Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Intracranial hypertension
Patients with raised intracranial pressure

Detailed Description:

The management of intracranial hypertension requires the presence of an intracranial pressure monitor. We are investigating whether the waveforms obtained from a near infrared spectroscopy device can predict what the intracranial pressure is non-invasively.

  • Patients with intracranial hypertension who are intubated and ventilated in the ICU will be recruited
  • we will record there intracranial pressure and systemic arterial pressure
  • recordings from the near infrared device will be recorded and analysed off-line
  • we will correlate the waveform tracings from near infrared spectroscopy and the arterial tracing

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients in the ICU with intracranial hypertension, being monitored with an arterial catheter and intraranial pressure monitor

Inclusion Criteria:

Patients with an intracranial pressure monitor and arterial catheter who are admitted to the ICU

Exclusion Criteria:

Less than 18 years

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01850069

Contact: Bhiken Naik, MBBCh 434-924-9454
Contact: Robert Thiele, MD

United States, Virginia
University of Virginia Recruiting
Charlottesville, Virginia, United States, 22908
Contact: Marcia E Birk, RN    434-924-2283   
Contact: Bhiken Naik, MBBCh    434-924-2283   
Principal Investigator: Bhiken Naik, MBBCh         
Sponsors and Collaborators
University of Virginia
Principal Investigator: Bhiken Naik, MBBCh University of Virginia
  More Information

Responsible Party: Bhiken I. Naik, MD, Assistant Professor, Anesthesiology, University of Virginia Identifier: NCT01850069     History of Changes
Other Study ID Numbers: 16714 
Study First Received: April 25, 2013
Last Updated: May 10, 2016
Health Authority: United States: Institutional Review Board

Keywords provided by University of Virginia:
Intracranial hypertension
intracranial elastance

Additional relevant MeSH terms:
Intracranial Hypertension
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases processed this record on May 30, 2016