The Use of Near Infrared Spectroscopy (NIRS) to Estimate Intracranial Pressure (ICP)
1 other identifier
observational
24
1 country
1
Brief Summary
The aim of this study is to determine whether we can predict the intracranial pressure using near infra-red spectroscopy
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Jun 2014
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 25, 2013
CompletedFirst Posted
Study publicly available on registry
May 9, 2013
CompletedStudy Start
First participant enrolled
June 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 10, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
January 10, 2017
CompletedMay 7, 2018
May 1, 2018
2.6 years
April 25, 2013
May 4, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Intracranial elastance
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.
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.
Study Arms (1)
Intracranial hypertension
Patients with raised intracranial pressure
Eligibility Criteria
Patients in the ICU with intracranial hypertension, being monitored with an arterial catheter and intraranial pressure monitor
You may qualify if:
- Patients with an intracranial pressure monitor and arterial catheter who are admitted to the ICU
You may not qualify if:
- Less than 18 years
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Virginia
Charlottesville, Virginia, 22908, United States
Related Publications (3)
Brain Trauma Foundation; American Association of Neurological Surgeons; Congress of Neurological Surgeons; Joint Section on Neurotrauma and Critical Care, AANS/CNS; Carney NA. Guidelines for the management of severe traumatic brain injury. Methods. J Neurotrauma. 2007;24 Suppl 1:S3-6. doi: 10.1089/neu.2007.9996. No abstract available.
PMID: 17511542BACKGROUNDRosenberg JB, Shiloh AL, Savel RH, Eisen LA. Non-invasive methods of estimating intracranial pressure. Neurocrit Care. 2011 Dec;15(3):599-608. doi: 10.1007/s12028-011-9545-4.
PMID: 21519957BACKGROUNDLee JK, Kibler KK, Benni PB, Easley RB, Czosnyka M, Smielewski P, Koehler RC, Shaffner DH, Brady KM. Cerebrovascular reactivity measured by near-infrared spectroscopy. Stroke. 2009 May;40(5):1820-6. doi: 10.1161/STROKEAHA.108.536094. Epub 2009 Mar 12.
PMID: 19286593BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Bhiken Naik, MBBCh
University of Virginia
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor, Anesthesiology
Study Record Dates
First Submitted
April 25, 2013
First Posted
May 9, 2013
Study Start
June 1, 2014
Primary Completion
January 10, 2017
Study Completion
January 10, 2017
Last Updated
May 7, 2018
Record last verified: 2018-05
Data Sharing
- IPD Sharing
- Will not share