Intracranial HypertensionNCT03865576
Validation of Non-Invasive Intracranial Pressure (ICP) Monitoring Device
An observational study of Intracranial Hypertension and Abnormality of Intracranial Pressure, run by Boston Neurosciences at 4 sites in United States.
Trial summary
For purposes of validation, this study compares intracranial pressure measurements obtained with a novel self-calibrating, non-invasive, intracranial pressure measuring (ICP) device, with the values obtained from (a) patients in an intensive care unit (ICU) whose meet standard clinical indications for ICP measurement… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Intracranial Hypertension, Abnormality of Intracranial Pressure
- What is being tested?
- Non-invasive ICP measurement
- How many people
- 80 participants
- Where
- 4 sitesUnited States
- Study dates
- 1 Mar 2019to 31 Oct 2019
- 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 hospitalized in an ICU who meet clinical criteria for invasive ICP measurement,
Who may be able to join
- ICU patients suspected of having an abnormality of ICP undergoing monitoring with commercially-available, FDA-approved instrumentation.
Who cannot join
- History of:
- Glaucoma or optic hypertension
- Severe orbital or ophthalmic injury
- Orbital or intraocular surgery that might interfere with orbital compliance
- Congenital malformations of the eye and/or orbit that might interfere with orbital compliance or orbital vascular anatomy
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Emory University Hospital
Atlanta, Georgia, 30322
Thomas Jefferson Hospital
Philadelphia, Pennsylvania, 19107
Honor Health Research Institute
Phoenix, Arizona, 85258
University of Washington
Seattle, Washington, 98195
About this study
Official title: Validation of a Non-Invasive Intracranial Pressure (ICP) Device by Comparison With Implanted Intracranial Pressure Monitoring Instrumentation or Lumbar Puncture
For purposes of validation, this study compares intracranial pressure measurements obtained with a novel self-calibrating, non-invasive, intracranial pressure measuring (ICP) device, with the values obtained from (a) patients in an intensive care unit (ICU) whose meet standard clinical indications for ICP measurement and whose ICP is measured using gold-standard implanted intracranial instrumentation and in (b) ambulatory subjects who meet clinical indications for lumbar puncture.
Read the detailed description
This study is designed to validate intracranial pressure measurements obtained with a novel, self-calibrating, non-invasive, intracranial pressure measuring (ICP) device based on trans-cranial Doppler technology. The ophthalmic artery is utilized as a natural ICP sensor. Up to 80 subjects will be recruited in 4 centers to achieve a power of 90% and a p<0.05 compared to the values obtained from (a) patients in an ICU whose meet standard clinical indications for ICP measurement and whose ICP is measured using gold-standard implanted intracranial instrumentation and in (b) ambulatory subjects who meet clinical indications for lumbar puncture. At least two comparative readings, separated by an hour or more, will be obtained from each subject.
- Being tested
- Non-invasive ICP measurement
- Keywords
- ICP, Papilledema, Neurological Intensive Care
- Medical subject headings
- Intracranial Hypertension, Papilledema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-invasive ICP measurementDiagnostic test
Intracranial pressure will be measured non-invasively using transorbital Doppler ultrasound. Values will be compared to ICP measured by lumbar puncture or implanted ICP sensors
| Study group | Role | What they receive |
|---|---|---|
| Thomas Jefferson University | Patients in intensive care with altered intracranial pressure.
Intervention: Non-invasive ICP measurement using transorbital Doppler ultrasound device.
Comparison of measurements obtained with values derived from surgically implanted ICP monitoring sensors. Receives: Diagnostic Test: Non-invasive ICP measurement | |
| Honor Health in Phoenix | Patients in intensive care with altered intracranial pressure.
Intervention: Non-invasive ICP measurement using transorbital Doppler ultrasound device.
Comparison of measurements obtained with values derived from surgically implanted ICP monitoring sensors. Receives: Diagnostic Test: Non-invasive ICP measurement | |
| Emory University Hospital in Atlanta | Patients in intensive care with altered intracranial pressure.
Intervention: Non-invasive ICP measurement using transorbital Doppler ultrasound device.
Comparison of measurements obtained with values derived from surgically implanted ICP monitoring sensors Receives: Diagnostic Test: Non-invasive ICP measurement | |
| University of Washington | Patients in intensive care with altered intracranial pressure.
Intervention: Non-invasive ICP measurement using transorbital Doppler ultrasound device. .
Comparison of measurements obtained with values derived from surgically implanted ICP monitoring sensors and lumbar puncture Receives: Diagnostic Test: Non-invasive ICP measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Non-invasive intracranial pressure (ICP) value
ICP value measured using novel non-invasive measurement device
Measured: Up to 5 days after admission to ICU
Second non-invasive intracranial pressure (ICP) value
A second measurement of ICP using novel non-invasive ICP measurement device
Measured: Up to 6 days after admission to ICU
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2019
- Study start1 Mar 2019
- Primary completion31 Oct 2019 (estimated)
- Study completion31 Oct 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intracranial HypertensionStudies of the same condition, open and under way.
- 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
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Boston Neurosciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- T Forcht Dagi, MD, DMedSc, Study director, Boston Neurosciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03865576
- Sponsor's protocol ID
- nICP-1
- Status last verified
- Mar 2019
- First submitted
- 28 Feb 2019
- Last updated
- 7 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of a Non-Invasive Intracranial Pressure (ICP) Device by Comparison With Implanted Intracranial Pressure Monitoring Instrumentation or Lumbar Puncture
- ClinicalTrials.gov ID
- NCT03865576
- Acronym / sponsor ID
- nICP-1
- Keywords
- ICP, Papilledema, Neurological Intensive Care
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Boston NeurosciencesIndustry (pharma, biotech, devices)
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- 31 Oct 2019 (estimated)
- Study completion
- 31 Oct 2019 (estimated)
- First posted
- 7 Mar 2019 (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.
For purposes of validation, this study compares intracranial pressure measurements obtained with a novel self-calibrating, non-invasive, intracranial pressure measuring (ICP) device, with the values obtained from (a) patients in an intensive care unit (ICU) whose meet standard clinical indications for ICP measurement and whose ICP is measured using gold-standard implanted intracranial instrumentation and in (b) ambulatory subjects who meet clinical indications for lumbar puncture.
Detailed description
This study is designed to validate intracranial pressure measurements obtained with a novel, self-calibrating, non-invasive, intracranial pressure measuring (ICP) device based on trans-cranial Doppler technology. The ophthalmic artery is utilized as a natural ICP sensor. Up to 80 subjects will be recruited in 4 centers to achieve a power of 90% and a p<0.05 compared to the values obtained from (a) patients in an ICU whose meet standard clinical indications for ICP measurement and whose ICP is measured using gold-standard implanted intracranial instrumentation and in (b) ambulatory subjects who meet clinical indications for lumbar puncture. At least two comparative readings, separated by an hour or more, will be obtained from each subject.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Thomas Jefferson University | – | Diagnostic Test: Non-invasive ICP measurementPatients in intensive care with altered intracranial pressure. Intervention: Non-invasive ICP measurement using transorbital Doppler ultrasound device. Comparison of measurements obtained with values derived from surgically implanted ICP monitoring sensors. |
| Honor Health in Phoenix | – | Diagnostic Test: Non-invasive ICP measurementPatients in intensive care with altered intracranial pressure. Intervention: Non-invasive ICP measurement using transorbital Doppler ultrasound device. Comparison of measurements obtained with values derived from surgically implanted ICP monitoring sensors. |
| Emory University Hospital in Atlanta | – | Diagnostic Test: Non-invasive ICP measurementPatients in intensive care with altered intracranial pressure. Intervention: Non-invasive ICP measurement using transorbital Doppler ultrasound device. Comparison of measurements obtained with values derived from surgically implanted ICP monitoring sensors |
| University of Washington | – | Diagnostic Test: Non-invasive ICP measurementPatients in intensive care with altered intracranial pressure. Intervention: Non-invasive ICP measurement using transorbital Doppler ultrasound device. . Comparison of measurements obtained with values derived from surgically implanted ICP monitoring sensors and lumbar puncture |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients hospitalized in an ICU who meet clinical criteria for invasive ICP measurement,
Key inclusion criteria (1 listed)
- ICU patients suspected of having an abnormality of ICP undergoing monitoring with commercially-available, FDA-approved instrumentation.
Key exclusion criteria (5 listed)
- Glaucoma or optic hypertension
- Severe orbital or ophthalmic injury
- Orbital or intraocular surgery that might interfere with orbital compliance
- Congenital malformations of the eye and/or orbit that might interfere with orbital compliance or orbital vascular anatomy
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 |
|---|---|---|
| Non-invasive ICP measurementIntracranial pressure will be measured non-invasively using transorbital Doppler ultrasound. Values will be compared to ICP measured by lumbar puncture or implanted ICP sensors | Diagnostic test | Emory University Hospital in Atlanta, Honor Health in Phoenix, Thomas Jefferson University, University of Washington |
Primary outcome
Non-invasive intracranial pressure (ICP) value
Time frame: Up to 5 days after admission to ICU
ICP value measured using novel non-invasive measurement device
Second non-invasive intracranial pressure (ICP) value
Time frame: Up to 6 days after admission to ICU
A second measurement of ICP using novel non-invasive ICP measurement device
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2019.
- 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.
T Forcht Dagi, MD, DMedSc study director
Boston Neurosciences
4 sites 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 and Abnormality of Intracranial Pressure, run by Boston Neurosciences at 4 sites 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 5 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 7 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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?
Results are not available in the source record.
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?
Non-invasive intracranial pressure (ICP) value (time frame: Up to 5 days after admission to ICU). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Mar 2019.