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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
April 25, 2013
May 9, 2013
October 26, 2016
June 2014
June 2017   (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. ]
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
Not Provided
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.
 
Recruiting
59
June 2017
June 2017   (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

Sexes Eligible for Study: All
18 Years to 80 Years   (Adult, Senior)
No
Contact: Bhiken Naik, MBBCh 434-924-9454
Contact: Robert Thiele, MD
United States
 
 
NCT01850069
16714
No
Not Provided
Plan to Share IPD: No
Bhiken I. Naik, MD, University of Virginia
University of Virginia
Not Provided
Principal Investigator: Bhiken Naik, MBBCh University of Virginia
University of Virginia
October 2016