Intracranial PressureSIM CityNCT01330264
Study of Intracranial Pressure (ICP) Monitoring in Critically Ill
An observational study of Intracranial Pressure, run by Duke University at 1 site in United States.
Trial summary
The SIM City study seeks to explore for the variance in practice that is associated with nursing and medical care of patients with brain pressure (ICP) monitors. The underlying hypothesis is that there is not a consistent pattern of care throughout the U.S., rather, there is a wide range of practice patterns that are… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intracranial Pressure
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2009to Mar 2012
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Patients admitted to the ICU that are receiving Intracranial Pressure (ICP) monitoring.
Who may be able to join
- Adult (18 years of age or older)
- Admitted to an Intensive Care Unit (ICU)
Who cannot join
- Prisoners
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Medical Center
Durham, North Carolina
About this study
Official title: Study of ICP Monitoring in Critically Ill
The SIM City study seeks to explore for the variance in practice that is associated with nursing and medical care of patients with brain pressure (ICP) monitors. The underlying hypothesis is that there is not a consistent pattern of care throughout the U.S., rather, there is a wide range of practice patterns that are used to monitor and treat ICP.
- Conditions
- Intracranial Pressure
- Keywords
- Intracranial Pressure (ICP) Monitoring, Admission to Intensive Care Unit (ICU)
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 |
|---|---|---|
| Dyad | Not described |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2011 (estimated)
- Study startJul 2009
- Primary completionMar 2012
- Study completionMar 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intracranial PressureStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe 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
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- DaiWai M Olson, PhD RN CCRN, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01330264
- Sponsor's protocol ID
- Pro00016075
- Acronym
- SIM City
- Status last verified
- Dec 2012
- First submitted
- 5 Apr 2011
- Last updated
- 11 Dec 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of ICP Monitoring in Critically Ill
- ClinicalTrials.gov ID
- NCT01330264
- Acronym / sponsor ID
- SIM City / Pro00016075
- Conditions
- Intracranial Pressure
- Keywords
- Intracranial Pressure (ICP) Monitoring, Admission to Intensive Care Unit (ICU)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- Jul 2009
- Primary completion
- Mar 2012 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 6 Apr 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.
The SIM City study seeks to explore for the variance in practice that is associated with nursing and medical care of patients with brain pressure (ICP) monitors. The underlying hypothesis is that there is not a consistent pattern of care throughout the U.S., rather, there is a wide range of practice patterns that are used to monitor and treat ICP.
Study design
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dyad | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients admitted to the ICU that are receiving Intracranial Pressure (ICP) monitoring.
Key inclusion criteria (2 listed)
- Adult (18 years of age or older)
- Admitted to an Intensive Care Unit (ICU)
Key exclusion criteria (1 listed)
- Prisoners
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
Not reported in the source record.
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 11 Dec 2012.
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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.
DaiWai M Olson, PhD RN CCRN principal investigator
Duke University
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 Duke University 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 2 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 11 Dec 2012. 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.
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 11 Dec 2012.