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

Intracranial Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01850069
• Other study ID #: 16714
• Status: Completed
• Start date: June 2014
• Est. completion date: January 10, 2017

Study information

• Verified date: May 2018
• Source: University of Virginia
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: January 10, 2017
• Est. primary completion date: January 10, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

Less than 18 years

Related Conditions & MeSH terms

• Hypertension
• Intracranial Hypertension

Locations

Country	Name	City	State
United States	University of Virginia	Charlottesville	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
University of Virginia

Country where clinical trial is conducted

United States, 

References & 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. Erratum in: J Neurotrauma. 2008 Mar;25(3):276-8. Carney, Nancy A [added]. — View Citation

Lee 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. — View Citation

Rosenberg 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intracranial elastance	Intracranial elastance (dP/dV)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.