Intracranial HypertensionNCT01850069
The Use of Near Infrared Spectroscopy (NIRS) to Estimate Intracranial Pressure (ICP)
An observational study of Intracranial Hypertension, run by University of Virginia at 1 site in United States.
Trial summary
The aim of this study is to determine whether we can predict the intracranial pressure using near infra-red spectroscopy Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Intracranial Hypertension
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2014to 10 Jan 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients in the ICU with intracranial hypertension, being monitored with an arterial catheter and intraranial pressure monitor
Who may be able to join
- Patients with an intracranial pressure monitor and arterial catheter who are admitted to the ICU
Who cannot join
- Less than 18 years
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Virginia
Charlottesville, Virginia, 22908
About this study
The aim of this study is to determine whether we can predict the intracranial pressure using near infra-red spectroscopy
Read the detailed 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
- Conditions
- Intracranial Hypertension
- Keywords
- Intracranial hypertension, intracranial elastance
- Medical subject headings
- Intracranial Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Intracranial hypertension | Patients with raised intracranial pressure |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2013 (estimated)
- Study startJun 2014
- Primary completion10 Jan 2017
- Study completion10 Jan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Intracranial HypertensionStudies of the same condition, open and under way.
- More trials run by University of VirginiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Virginia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bhiken I. Naik, MD, University of Virginia
- Investigators
- Bhiken Naik, MBBCh, Principal investigator, University of Virginia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01850069
- Sponsor's protocol ID
- 16714
- Status last verified
- May 2018
- First submitted
- 25 Apr 2013
- Last updated
- 7 May 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 17511542Rosenberg 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.
PubMed 21519957Lee 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.
PubMed 19286593
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Near Infrared Spectroscopy (NIRS) to Estimate Intracranial Pressure (ICP)
- ClinicalTrials.gov ID
- NCT01850069
- Acronym / sponsor ID
- 16714
- Conditions
- Intracranial Hypertension
- Keywords
- Intracranial hypertension, intracranial elastance
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University of VirginiaUniversity, hospital or other
- Study start
- Jun 2014 (actual)
- Primary completion
- 10 Jan 2017 (actual)
- Study completion
- 10 Jan 2017 (actual)
- First posted
- 9 May 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to determine whether we can predict the intracranial pressure using near infra-red spectroscopy
Detailed 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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intracranial hypertension | – | –Patients with raised intracranial pressure |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients in the ICU with intracranial hypertension, being monitored with an arterial catheter and intraranial pressure monitor
Key inclusion criteria (1 listed)
- Patients with an intracranial pressure monitor and arterial catheter who are admitted to the ICU
Key exclusion criteria (1 listed)
- Less than 18 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2018.
- Background: PubMed 17511542Brain 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.
- Background: PubMed 21519957Rosenberg 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.
- Background: PubMed 19286593Lee 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.
- Individual participant dataSharing planned: No
Related trials for Intracranial Hypertension
Not yet recruitingObservational study
Assessment of Optic Sheat Diameter (ONSD) and Eyeball Transverse Diameter (ETD) Ratio Measurement From Ocular Ultrasound
Optic Nerve Sheath Diameter Measurement, Intracranial Pressure Increase
Not yet recruitingObservational study
Multimodal MRI Assessment of Brain Fluid Circulation in Idiopathic Intracranial Hypertension
Idiopathic Intracranial Hypertension
RecruitingObservational study
Clevidipine for the Antihypertensive Treatment of Acute Intracerebral Hemorrhage
Intracerebral Hemorrhage, Stroke
Recruiting
Low Pneumoperitoneum Pressure for Delirium Prevention in Elderly Laparoscopy
Postoperative Delirium (POD), Intracranial Hypertension
RecruitingObservational study
Predict Severe Traumatic Brain Injury
Traumatic Brain Injury
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bhiken Naik, MBBCh principal investigator
University of Virginia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Intracranial Hypertension, run by University of Virginia at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01850069, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2018.