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

This study is currently recruiting participants.
Verified October 2016 by Bhiken I. Naik, MD, University of Virginia
Sponsor:
ClinicalTrials.gov Identifier:
NCT01850069
First Posted: May 9, 2013
Last Update Posted: October 26, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Bhiken I. Naik, MD, University of Virginia
  Purpose
The aim of this study is to determine whether we can predict the intracranial pressure using near infra-red spectroscopy

Condition
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)

Further study details as provided by Bhiken I. Naik, MD, 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. ]
    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 2017
Estimated Primary Completion Date: June 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts
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
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Criteria

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01850069


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

Locations
United States, Virginia
University of Virginia Recruiting
Charlottesville, Virginia, United States, 22908
Contact: Marcia E Birk, RN    434-924-2283    meb2w@virginia.edu   
Contact: Bhiken Naik, MBBCh    434-924-2283    bin4n@virginia.edu   
Principal Investigator: Bhiken Naik, MBBCh         
Sponsors and Collaborators
University of Virginia
Investigators
Principal Investigator: Bhiken Naik, MBBCh University of Virginia
  More Information

Publications:
Responsible Party: Bhiken I. Naik, MD, Assistant Professor, Anesthesiology, University of Virginia
ClinicalTrials.gov Identifier: NCT01850069     History of Changes
Other Study ID Numbers: 16714
First Submitted: April 25, 2013
First Posted: May 9, 2013
Last Update Posted: October 26, 2016
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Bhiken I. Naik, MD, University of Virginia:
Intracranial hypertension
intracranial elastance

Additional relevant MeSH terms:
Hypertension
Intracranial Hypertension
Vascular Diseases
Cardiovascular Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases