Intracranial PressureNCT03382860
Estimation of Intracranial Pressure Using Non-invasive Fundus Videos
An observational study of Intracranial Pressure, run by Odense University Hospital at 1 site in Denmark.
Trial summary
The purpose of this pilot study is to assess whether the intracranial pressure (ICP) can be detected by using a non-invasive retinal fundus scanner, recording the vessels of the eye entering from the optic disc. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intracranial Pressure
- What is being tested?
- Fundus videos
- How many people
- 50 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Jun 2017to 1 Aug 2025
- 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 years and older
- All sexes
- Adult, Older adult
Study population: All conscious and able patients of 18 years and older admitted for intracranial pressure monitoring in the department of neurosurgery (Camino, Integra, Switzerland)
Who may be able to join
- Adults 18 years or older with indication for intraparenchymal or intraventricular ICP monitoring
- Conscious and able
- Admission to the Department of Neurosurgery or Department of Neurology at Odense University Hospital
Who cannot join
- Disabled and unconscious
- No intraparenchymal or intraventricular ICP monitoring
Trial locations and contacts
1 site in 1 country.
Denmark1 site, 1 recruiting
- Recruiting
Department of Neurosurgery, Odense University Hospital
Odense C, Danmark, 5000
Frantz R Poulsen, MD, PhD, 65411835 ext. 0045, frantz.r.poulsen@rsyd.dk
Mikkel S Andersen, MD, 25618181 ext. 0045, mikkel.c.schou.andersen@rsyd.dk
About this study
The purpose of this pilot study is to assess whether the intracranial pressure (ICP) can be detected by using a non-invasive retinal fundus scanner, recording the vessels of the eye entering from the optic disc. The artery's diameter (A) is measured and compared to the vein's diameter (V) thereby a ratio A/V can be calculated. This ratio is compared to the values obtained from conventional fiberoptic intraparenchymal, intraventricular ICP monitoring using external ventricular drain (EVD) or lumbar pressure monitoring.
Valid non-invasive techniques for objective measurements of the intracranial pressure do not exist at the given time now and this study could prove to help the development of monitoring patients ICP without surgical intervention.
Read the detailed description
Intracranial pressure (ICP) is based on the simple principle of Monroe-Kellie Doctrine. Since the volume of the cranial cavity is constant and the brain, CSF and blood can only compensate for a certain change in volume, pressure will increase at a critical increase in volume. An increase in pressure caused by an increase in intracranial volume is distributed throughout the entire brain and spinal canal equally. The normal range of ICP varies with age. Normal values are less than 10-15 mmHg for adults and adolescents, 3-7 mmHg for younger children and 1.5-6 mmHg for newborns even sub-atmospheric ICP has been shown.
The threshold for intracranial hypertension varies in the literature, which is reflected in the clinical use. Generally, ICP above 20 mmHg is defined intracranial hypertension. ICP higher than 20-25 may require treatment, and continuous ICP above 40 mmHg indicates severe, lethal intracranial hypertension.
Some forms of measurements, e.g. 1. Intraparenchymal strain gauge or fiber optics or 2. Intraventricular ICP monitoring via external ventricular drain (EVD). EVD is considered golden standard, but in the daily clinic there is often no or limited difference between 1. and 2. The issue regarding invasive methods are the same as for any surgical procedure, e.g. bleeding and infection. Risk of bleeding is 2-10% for EVD and 2.5% for intraparenchymal monitors. The consequences of such a bleed can be severe and result in disability. EVD has a higher risk of infection (5-20%) compared to intraparenchymal monitors (0-0.1%).
Non-invasive methods such as transcranial doppler ultrasound pulsation index and optic nerve sheath diameter has been used in studies, which seemed promising, but has not yet been validated for routine clinical use. Also, in non-invasive methods there are significant inter observational variation.
Studies of the eye's fundus have shown a correlation between ICP and ratio between artery and vein diameter (A/V ratio, unpublished data) Currently, there are no published work that has considered the correlation between A/V ratio and ICP, however there is a study with a theoretical prediction of such a correlation (Babbs CF 2016. Weldon School of Biomedical Engineering Faculty Working Papers. Paper 1 http://docs.lib.purdue.edu/bmewp/1).
This study investigates the correlation between non-invasive fundus ICP estimation and intracranial pressure monitoring.
In practice, all conscious and able adults admitted to Odense University Hospital for intracranial pressure monitoring/measurements by either an EVD, intraparenchymal ICP monitor or lumbar spinal fluid pressure assessment are enrolled.
- Conditions
- Intracranial Pressure
- Being tested
- Fundus videos
- Keywords
- Intracranial Hypertension, Intracranial pressure monitoring, Non-invasive point-of-care device, Normal pressure hydrocephalus
- Medical subject headings
- Intracranial Hypertension, Hydrocephalus, Normal Pressure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fundus videosDiagnostic test
Recordings of fundus videos
| Study group | Role | What they receive |
|---|---|---|
| Ventriculoperitoneal dysfunction | Patients with suspected ventriculo-peritoneal (VP) shunt dysfunction are admitted to the neurosurgical department for intracranial pressure monitoring for 24 hours. The patients are approached within this time frame. Receives: Diagnostic Test: Fundus videos | |
| Normal Pressure Hydrocephalus (NPH) | Patients with suspected NPH (triad of cognitive dysfunction, urine incontinence of urge type, abnormal gait) are admitted to the neurosurgical department for intracranial pressure monitoring for 24 hours. The following day an infusiontest is performed, where data is collected. Receives: Diagnostic Test: Fundus videos |
What is being measured
The primary outcome is the main question the study is designed to answer.
Absolute A/V ratio value to conventional intracranial pressure monitors
Comparison of A/V ratio values from the fundus video analysis and conventional intraparenchymal intracranial pressure (ICP), intraventricular ICP monitoring or lumbar pressure monitoring.
Measured: 2025
Secondary outcomes (1)
Change in A/V ratio value compared to increased intracranial pressure monitor during infusion test.
Assessment of the use of the fundus videos in patients undergoing a lumbar infusion test for 20 minutes for assessment of normal intracranial pressure compared to a conventional intraparenchymal ICP monitor.
Measured: 2025
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2017
- Study start1 Jun 2017
- Primary completion1 Aug 2025 (estimated)
- Study completion1 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Intracranial PressureStudies of the same condition, open and under way.
- More trials run by Odense University HospitalThe 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
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Odense University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Statumanu Icp ApS
- Responsible party
- Principal investigator, Frantz Rom Poulsen, Odense University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03382860
- Sponsor's protocol ID
- S-20170038
- Other IDs
- 2012-58-0018
- Status last verified
- May 2023
- First submitted
- 19 Dec 2017
- Last updated
- 2 Jun 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: We wish to share all data of individual intracranial pressure values and A/V ratio.
Publications
Andersen MS, Pedersen CB, Poulsen FR. A new novel method for assessing intracranial pressure using non-invasive fundus images: a pilot study. Sci Rep. 2020 Aug 3;10(1):13062. doi: 10.1038/s41598-020-70084-0.
PubMed 32747697
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Estimation of Intracranial Pressure Using Non-invasive Fundus Videos
- ClinicalTrials.gov ID
- NCT03382860
- Acronym / sponsor ID
- S-20170038
- Conditions
- Intracranial Pressure
- Keywords
- Intracranial Hypertension, Intracranial pressure monitoring, Non-invasive point-of-care device, Normal pressure hydrocephalus
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Odense University HospitalUniversity, hospital or other
- Collaborators
- Statumanu Icp ApS
- Study start
- 1 Jun 2017 (actual)
- Primary completion
- 1 Aug 2025 (estimated)
- Study completion
- 1 Aug 2025 (estimated)
- First posted
- 26 Dec 2017 (actual)
- 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 purpose of this pilot study is to assess whether the intracranial pressure (ICP) can be detected by using a non-invasive retinal fundus scanner, recording the vessels of the eye entering from the optic disc. The artery's diameter (A) is measured and compared to the vein's diameter (V) thereby a ratio A/V can be calculated. This ratio is compared to the values obtained from conventional fiberoptic intraparenchymal, intraventricular ICP monitoring using external ventricular drain (EVD) or lumbar pressure monitoring.
Valid non-invasive techniques for objective measurements of the intracranial pressure do not exist at the given time now and this study could prove to help the development of monitoring patients ICP without surgical intervention.
Detailed description
Intracranial pressure (ICP) is based on the simple principle of Monroe-Kellie Doctrine. Since the volume of the cranial cavity is constant and the brain, CSF and blood can only compensate for a certain change in volume, pressure will increase at a critical increase in volume. An increase in pressure caused by an increase in intracranial volume is distributed throughout the entire brain and spinal canal equally. The normal range of ICP varies with age. Normal values are less than 10-15 mmHg for adults and adolescents, 3-7 mmHg for younger children and 1.5-6 mmHg for newborns even sub-atmospheric ICP has been shown.
The threshold for intracranial hypertension varies in the literature, which is reflected in the clinical use. Generally, ICP above 20 mmHg is defined intracranial hypertension. ICP higher than 20-25 may require treatment, and continuous ICP above 40 mmHg indicates severe, lethal intracranial hypertension.
Some forms of measurements, e.g. 1. Intraparenchymal strain gauge or fiber optics or 2. Intraventricular ICP monitoring via external ventricular drain (EVD). EVD is considered golden standard, but in the daily clinic there is often no or limited difference between 1. and 2. The issue regarding invasive methods are the same as for any surgical procedure, e.g. bleeding and infection. Risk of bleeding is 2-10% for EVD and 2.5% for intraparenchymal monitors. The consequences of such a bleed can be severe and result in disability. EVD has a higher risk of infection (5-20%) compared to intraparenchymal monitors (0-0.1%).
Non-invasive methods such as transcranial doppler ultrasound pulsation index and optic nerve sheath diameter has been used in studies, which seemed promising, but has not yet been validated for routine clinical use. Also, in non-invasive methods there are significant inter observational variation.
Studies of the eye's fundus have shown a correlation between ICP and ratio between artery and vein diameter (A/V ratio, unpublished data) Currently, there are no published work that has considered the correlation between A/V ratio and ICP, however there is a study with a theoretical prediction of such a correlation (Babbs CF 2016. Weldon School of Biomedical Engineering Faculty Working Papers. Paper 1 http://docs.lib.purdue.edu/bmewp/1).
This study investigates the correlation between non-invasive fundus ICP estimation and intracranial pressure monitoring.
In practice, all conscious and able adults admitted to Odense University Hospital for intracranial pressure monitoring/measurements by either an EVD, intraparenchymal ICP monitor or lumbar spinal fluid pressure assessment are enrolled.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ventriculoperitoneal dysfunction | – | Diagnostic Test: Fundus videosPatients with suspected ventriculo-peritoneal (VP) shunt dysfunction are admitted to the neurosurgical department for intracranial pressure monitoring for 24 hours. The patients are approached within this time frame. |
| Normal Pressure Hydrocephalus (NPH) | – | Diagnostic Test: Fundus videosPatients with suspected NPH (triad of cognitive dysfunction, urine incontinence of urge type, abnormal gait) are admitted to the neurosurgical department for intracranial pressure monitoring for 24 hours. The following day an infusiontest is performed, where data is collected. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- All conscious and able patients of 18 years and older admitted for intracranial pressure monitoring in the department of neurosurgery (Camino, Integra, Switzerland)
Key inclusion criteria (3 listed)
- Adults 18 years or older with indication for intraparenchymal or intraventricular ICP monitoring
- Conscious and able
- Admission to the Department of Neurosurgery or Department of Neurology at Odense University Hospital
Key exclusion criteria (2 listed)
- Disabled and unconscious
- No intraparenchymal or intraventricular ICP monitoring
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fundus videosRecordings of fundus videos | Diagnostic test | Normal Pressure Hydrocephalus (NPH), Ventriculoperitoneal dysfunction |
Primary outcome
Absolute A/V ratio value to conventional intracranial pressure monitors
Time frame: 2025
Comparison of A/V ratio values from the fundus video analysis and conventional intraparenchymal intracranial pressure (ICP), intraventricular ICP monitoring or lumbar pressure monitoring.
1 secondary outcome
Change in A/V ratio value compared to increased intracranial pressure monitor during infusion test.
Time frame: 2025
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2023.
- Results publication: PubMed 32747697Andersen MS, Pedersen CB, Poulsen FR. A new novel method for assessing intracranial pressure using non-invasive fundus images: a pilot study. Sci Rep. 2020 Aug 3;10(1):13062. doi: 10.1038/s41598-020-70084-0.
- Biomechanics of Retinal Venous Pulsations as Indicators of Intracranial PressureLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided. We wish to share all data of individual intracranial pressure values and A/V ratio.
Related trials for Intracranial Pressure
RecruitingObservational study
Intracranial Pressure Monitoring in Moderate Traumatic Brain Injury
Moderate Traumatic Brain Injury
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
RecruitingObservational study
Effect of Ketamine on Optic Nerve Sheath Diameter During Procedural Analgesia
Procedural Pain, Procedural Sedation and Analgesia
Recruiting
Low Pneumoperitoneum Pressure for Delirium Prevention in Elderly Laparoscopy
Postoperative Delirium (POD), Intracranial Hypertension
RecruitingObservational study
CoMind Early Feasibility Study
Intracranial Pressure, Intracranial Pressure Changes
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.
Department of Neurosurgery, Odense University Hospital
Odense C, Denmark
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 Pressure, run by Odense University Hospital at 1 site in Denmark.
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 3 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 2 Jun 2023. 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 Denmark. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Absolute A/V ratio value to conventional intracranial pressure monitors (time frame: 2025). 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 NCT03382860, which also lists 1 linked publication.
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 2 Jun 2023.