Intracranial HypertensionNCT01448681
A Continuous, Non-Invasive, Real-time Method for Estimating and Predicting Intracranial Hypertension
An observational study of Intracranial Hypertension and Elevated ICP (Intracranial Pressure), run by University of Colorado, Denver at 1 site in United States.
Trial summary
There is statistically significant correlation between invasive measures of intracranial pressure (ICP) and non-invasive, real-time, continuous physiologic waveform data algorithms to predict ICP. Read more about this study
- Who is it for?
- Ages 18 to 89 years
- Conditions the study is for
- Intracranial Hypertension, Elevated ICP (Intracranial Pressure)
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2011to Jul 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 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Surgical intensive care unit patients
Who may be able to join
- patients with severe traumatic brain injury resulting in motor Glasgow Coma Score (GCS) score < 5
- age 18-89 years
- health care provider indicating the need for hyperosmolar therapy for elevated ICP
Who cannot join
- pregnancy
- incarceration
- brain death (GCS 3 with fixed, dilated pupils)
- life-threatening systemic injuries (Abbreviated Injury Scale (AIS) >4 in an organ system other than CNS)
Trial locations and contacts
1 site in 1 country.
United States1 site
Denver Health Medical Center
Denver, Colorado, 80204
About this study
There is statistically significant correlation between invasive measures of intracranial pressure (ICP) and non-invasive, real-time, continuous physiologic waveform data algorithms to predict ICP. Furthermore, characteristics within this physiologic waveform data will allow modeling for trend prediction of derived ICP information. Specific aims:
- Develop models to estimate ICP and cerebral perfusion pressure (CPP) after traumatic brain injury in humans.
- Predict and anticipate changes in ICP for preemptive management purposes.
- Analyze characteristics of changes in ICP after treatment failure.
- Analyze data to predict/anticipate confounding physiologic factors that affect ICP and its treatment.
- Test the resulting models in real time.
- Being tested
- No Interventions
- Keywords
- Intracranial Hypertension, Elevated ICP (Intracranial Pressure)
- Medical subject headings
- Intracranial Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No InterventionsOther
| Study group | Role | What they receive |
|---|---|---|
| SICU patients with ICP | Surgical intensive care unit patients with elevated intracranial pressure Receives: Other: No Interventions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Algorithm development
Developing algorithms relating data to intracranial pressure.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2011 (estimated)
- Study startAug 2011
- Primary completionJul 2019
- Study completionJul 2019
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.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Steven Moulton, MD, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01448681
- Sponsor's protocol ID
- 10-1412
- Status last verified
- Sep 2019
- First submitted
- 5 Oct 2011
- Last updated
- 30 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Continuous, Non-Invasive, Real-time Method for Estimating and Predicting Intracranial Hypertension
- ClinicalTrials.gov ID
- NCT01448681
- Acronym / sponsor ID
- 10-1412
- Keywords
- Intracranial Hypertension, Elevated ICP (Intracranial Pressure)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Study start
- Aug 2011 (actual)
- Primary completion
- Jul 2019 (actual)
- Study completion
- Jul 2019 (actual)
- First posted
- 7 Oct 2011 (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.
There is statistically significant correlation between invasive measures of intracranial pressure (ICP) and non-invasive, real-time, continuous physiologic waveform data algorithms to predict ICP. Furthermore, characteristics within this physiologic waveform data will allow modeling for trend prediction of derived ICP information. Specific aims:
- Develop models to estimate ICP and cerebral perfusion pressure (CPP) after traumatic brain injury in humans.
- Predict and anticipate changes in ICP for preemptive management purposes.
- Analyze characteristics of changes in ICP after treatment failure.
- Analyze data to predict/anticipate confounding physiologic factors that affect ICP and its treatment.
- Test the resulting models in real time.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SICU patients with ICP | – | Other: No InterventionsSurgical intensive care unit patients with elevated intracranial pressure |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Surgical intensive care unit patients
Key inclusion criteria (3 listed)
- patients with severe traumatic brain injury resulting in motor Glasgow Coma Score (GCS) score < 5
- age 18-89 years
- health care provider indicating the need for hyperosmolar therapy for elevated ICP
Key exclusion criteria (4 listed)
- pregnancy
- incarceration
- brain death (GCS 3 with fixed, dilated pupils)
- life-threatening systemic injuries (Abbreviated Injury Scale (AIS) >4 in an organ system other than CNS)
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 |
|---|---|---|
| No Interventions | Other | SICU patients with ICP |
Primary outcome
Algorithm development
Time frame: 24 months
Developing algorithms relating data to intracranial pressure.
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 30 Sep 2019.
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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.
Steven Moulton, MD principal investigator
University of Colorado, Denver
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 and Elevated ICP (Intracranial Pressure), run by University of Colorado, Denver 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 3 inclusion and 4 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 30 Sep 2019. 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?
Algorithm development (time frame: 24 months). 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 30 Sep 2019.