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

April 25, 2013
May 6, 2013
June 2013
June 2014   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01850069 on ClinicalTrials.gov Archive Site
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The Use of Near Infrared Spectroscopy (NIRS) to Estimate Intracranial Pressure (ICP)
The Use of Near Infrared Spectroscopy (NIRS) to Estimate Intracranial Pressure (ICP)

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

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
Observational
Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample

Patients in the ICU with intracranial hypertension, being monitored with an arterial catheter and intraranial pressure monitor

Intracranial Hypertension
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Intracranial hypertension
Patients with raised intracranial pressure

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
59
June 2014
June 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

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

Exclusion Criteria:

Less than 18 years

Both
18 Years to 80 Years
No
Contact: Bhiken Naik, MBBCh 434-924-9454
Contact: Robert Thiele, MD
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NCT01850069
16714
No
University of Virginia
University of Virginia
Not Provided
Principal Investigator: Bhiken Naik, MBBCh University of Virginia
University of Virginia
May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP