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Completed

NCT Number: NCT01850069

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

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Key information

Conditions

Intracranial Hypertension Brain Diseases Central Nervous System Diseases Nervous System Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Virginia

Charlottesville, Virginia, 22908, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

Less than 18 years

Treatment and study plan

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

University of Virginia

Other

Registry information

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
May 9, 2013
Registry last updated
May 7, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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