HydrocephalusNCT02404740
Noninvasive Intracranial Pressure and Hydrocephalus Patients
An observational study of Hydrocephalus, run by University of Colorado, Denver.
Trial summary
Using a pulse oximeter, we have developed an algorithm that estimates intracranial pressure (ICP) based on patients who have had traumatic brain injuries. Patients with hydrocephalus are typically treated with a shunt in order to reduce ICP. At times the shunt can malfunction. Read more about this study
- Who is it for?
- Ages 31 days to 35 years
- Conditions the study is for
- Hydrocephalus
- What is being tested?
- Pulse oximetry
- Type of treatment
- Medical device
- How many people
- 163 participants
- Where
- No sites listed yet
- Study dates
- Feb 2015to Sep 2018
- 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 31 days to 35 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: VP shunted patient, Normal intracranial pathology patient
Who may be able to join
- Age: 31 days - 35 years
- Patients seen at Children's Hospital Colorado Neurosurgery clinic, Emergency Department or on an inpatient service
- Either hydrocephalus patients with a VP shunt in place (with or without suspicion of VP shunt malfunction), or patients with no known intracranial pathology.
Who cannot join
- Pregnant patients
- Incarcerated patients
- Patients who object at any time to participating in the study.
About this study
Official title: Continuous Noninvasive Estimation of Intracranial Pressure to Assess Ventriculoperitoneal Shunt Malfunction in Patients With Hydrocephalus
Using a pulse oximeter, we have developed an algorithm that estimates intracranial pressure (ICP) based on patients who have had traumatic brain injuries. Patients with hydrocephalus are typically treated with a shunt in order to reduce ICP. At times the shunt can malfunction. We believe that our algorithm will help identify when a hydrocephalus patient's shunt has malfunctioned.
Read the detailed description
A malfunctioning ventriculoperitoneal (VP) shunt will typically cause a rise in intracranial pressure, which can be difficult to identify without costly imaging. Novel, state-of-the art machine learning techniques can be leveraged to develop an algorithm that noninvasively estimates intracranial pressure. The resulting algorithm will accurately determine the presence or absence of ventriculoperitoneal shunt malfunction in patients with hydrocephalus.
- Conditions
- Hydrocephalus
- Being tested
- Pulse oximetry
- Keywords
- VP shunted, Normal intracranial pathology, patients
- Medical subject headings
- Hydrocephalus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pulse oximetryDevice
Pulse oximetry
| Study group | Role | What they receive |
|---|---|---|
| VP shunt functioning | No intervention, just a physiological category--patients with VP shunts that are functioning normally. Receives: Device: Pulse oximetry | |
| VP shunt malfunctioning | No intervention, just a physiological category--patients with VP shunts that are malfunctioning. Receives: Device: Pulse oximetry | |
| No known intracranial pathology | No intervention, just a physiological category--patients without VP shunts that have no known intracranial pathology. Receives: Device: Pulse oximetry |
What is being measured
The primary outcome is the main question the study is designed to answer.
The presence or absence of ventriculoperitoneal shunt malfunction in patients with hydrocephalus
The algorithm development
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2015 (estimated)
- Study startFeb 2015
- Primary completionSep 2018
- Study completionSep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HydrocephalusStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe 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
- 163 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Steve Moulton, MD, Principal investigator, Children's Hospital Colorado
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02404740
- Sponsor's protocol ID
- 14-1995
- Status last verified
- Oct 2019
- First submitted
- 26 Mar 2015
- Last updated
- 4 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Continuous Noninvasive Estimation of Intracranial Pressure to Assess Ventriculoperitoneal Shunt Malfunction in Patients With Hydrocephalus
- ClinicalTrials.gov ID
- NCT02404740
- Acronym / sponsor ID
- 14-1995
- Conditions
- Hydrocephalus
- Keywords
- VP shunted, Normal intracranial pathology, patients
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 163 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Study start
- Feb 2015
- Primary completion
- Sep 2018 (actual)
- Study completion
- Sep 2018 (actual)
- First posted
- 31 Mar 2015 (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.
Using a pulse oximeter, we have developed an algorithm that estimates intracranial pressure (ICP) based on patients who have had traumatic brain injuries. Patients with hydrocephalus are typically treated with a shunt in order to reduce ICP. At times the shunt can malfunction. We believe that our algorithm will help identify when a hydrocephalus patient's shunt has malfunctioned.
Detailed description
A malfunctioning ventriculoperitoneal (VP) shunt will typically cause a rise in intracranial pressure, which can be difficult to identify without costly imaging. Novel, state-of-the art machine learning techniques can be leveraged to develop an algorithm that noninvasively estimates intracranial pressure. The resulting algorithm will accurately determine the presence or absence of ventriculoperitoneal shunt malfunction in patients with hydrocephalus.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| VP shunt functioning | – | Device: Pulse oximetryNo intervention, just a physiological category--patients with VP shunts that are functioning normally. |
| VP shunt malfunctioning | – | Device: Pulse oximetryNo intervention, just a physiological category--patients with VP shunts that are malfunctioning. |
| No known intracranial pathology | – | Device: Pulse oximetryNo intervention, just a physiological category--patients without VP shunts that have no known intracranial pathology. |
Who may qualify
- Ages
- 31 days to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- VP shunted patient, Normal intracranial pathology patient
Key inclusion criteria (3 listed)
- Age: 31 days - 35 years
- Patients seen at Children's Hospital Colorado Neurosurgery clinic, Emergency Department or on an inpatient service
- Either hydrocephalus patients with a VP shunt in place (with or without suspicion of VP shunt malfunction), or patients with no known intracranial pathology.
Key exclusion criteria (3 listed)
- Pregnant patients
- Incarcerated patients
- Patients who object at any time to participating in the study.
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 |
|---|---|---|
| Pulse oximetryPulse oximetry | Device | No known intracranial pathology, VP shunt functioning, VP shunt malfunctioning |
Primary outcome
The presence or absence of ventriculoperitoneal shunt malfunction in patients with hydrocephalus
Time frame: baseline
The algorithm development
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 4 Oct 2019.
- Individual participant dataSharing planned: No
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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.
Steve Moulton, MD principal investigator
Children's Hospital Colorado
Questions about this trial
What is this clinical trial studying?
An observational study of Hydrocephalus, run by University of Colorado, Denver.
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 3 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 4 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
The presence or absence of ventriculoperitoneal shunt malfunction in patients with hydrocephalus (time frame: baseline). 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 4 Oct 2019.