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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified May 2013 by University of Virginia
Sponsor:
Information provided by (Responsible Party):
University of Virginia
ClinicalTrials.gov Identifier:
NCT01850069
First received: April 25, 2013
Last updated: May 6, 2013
Last verified: May 2013
  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)

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 2013
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: June 2014 (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

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

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
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 ClinicalTrials.gov identifier: NCT01850069

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

Sponsors and Collaborators
University of Virginia
Investigators
Principal Investigator: Bhiken Naik, MBBCh University of Virginia
  More Information

Publications:
Responsible Party: University of Virginia
ClinicalTrials.gov Identifier: NCT01850069     History of Changes
Other Study ID Numbers: 16714
Study First Received: April 25, 2013
Last Updated: May 6, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by 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

ClinicalTrials.gov processed this record on July 24, 2014