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

Sponsor
University of Virginia (Other)
Overall Status
Completed
CT.gov ID
NCT01850069
Collaborator
(none)
24
1
31.3
0.8

Study Details

Study Description

Brief Summary

The aim of this study is to determine whether we can predict the intracranial pressure using near infra-red spectroscopy

Condition or Disease Intervention/Treatment Phase

    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

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    24 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    The Use of Near Infrared Spectroscopy (NIRS) to Estimate Intracranial Pressure (ICP)
    Actual Study Start Date :
    Jun 1, 2014
    Actual Primary Completion Date :
    Jan 10, 2017
    Actual Study Completion Date :
    Jan 10, 2017

    Arms and Interventions

    Arm Intervention/Treatment
    Intracranial hypertension

    Patients with raised intracranial pressure

    Outcome Measures

    Primary Outcome Measures

    1. Intracranial elastance [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.]

      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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 University of Virginia Charlottesville Virginia United States 22908

    Sponsors and Collaborators

    • University of Virginia

    Investigators

    • Principal Investigator: Bhiken Naik, MBBCh, University of Virginia

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Bhiken I. Naik, MD, Assistant Professor, Anesthesiology, University of Virginia
    ClinicalTrials.gov Identifier:
    NCT01850069
    Other Study ID Numbers:
    • 16714
    First Posted:
    May 9, 2013
    Last Update Posted:
    May 7, 2018
    Last Verified:
    May 1, 2018
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Keywords provided by Bhiken I. Naik, MD, Assistant Professor, Anesthesiology, University of Virginia
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of May 7, 2018