Ventriculostomies in SAH: ICP Open or Not? (VISION)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00787020
Recruitment Status : Completed
First Posted : November 7, 2008
Results First Posted : December 17, 2010
Last Update Posted : November 3, 2015
Information provided by (Responsible Party):
Duke University

Brief Summary:
The purpose of this study is explore how cerebrospinal fluid (CSF) drainage impacts outcomes for patients diagnosed with subarachnoid hemorrhage (SAH). This is a non-randomized observational study of two physician-prescribed approaches to managing intracranial pressure monitoring and CSF drainage for SAH patients. The study will enroll only those patients who have intracranial pressure (ICP) monitoring in situ. Because this is an observational study, there are no physical risks to the patient, the only risk is loss of confidentiality.

Condition or disease
Subarachnoid Hemorrhage

Detailed Description:

There are no interventions specific to this observational study. The nurses and physicians who care for subjects in the study are already competent in the care and management of patients with subarachnoid hemorrhage (SAH) and intracranial pressure (ICP) monitoring as a requirement of their current employment at Duke University. Patients with confirmed diagnosis of subarachnoid hemorrhage requiring ICP and CSF management will be admitted to the 16 bed Neurocritical Care Unit (NCCU) at Duke Hospital. After admission procedures and a baseline neurologic assessment are complete, the charge nurse or NCCU fellow will notify an investigator of subjects meeting inclusion criteria. The investigator or research coordinator for this project will complete a review preparatory to research (RPR) to ensure no exclusion criteria are present and once subject appropriateness has been confirmed patients and their families will be introduced to the investigator for the purpose of obtaining informed consent. The subject's legally authorized representative (LAR) will be informed of the study's purpose, risks and benefits, and the rights of research subjects.

Data will be collected that reflects the duration of the patient's hospitalization at Duke University through chart abstraction. The study period will be defined as admission to discharge. The attending physician has, and will continue to, determine the appropriateness of the duration of ICP monitoring, NCCU discharge criteria and hospital discharge criteria. Chart abstraction will be completed daily to obtain the ICP values and CSF volumes during that period of time for which the patient has a ventriculostomy.

Study Type : Observational
Actual Enrollment : 37 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: Ventriculostomies in SAH: ICP Open or Not?
Study Start Date : November 2008
Actual Primary Completion Date : August 2009
Actual Study Completion Date : February 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding

Ventriculostomy Open
Subjects are treated with near continuous cerebrospinal fluid (CSF) diversion by positioning the stopcock in the open position and the intracranial pressure (ICP) is monitored once each hour: CSF drains into an external ventricular drainage bag.
Ventriculostomy Monitored
Subjects are treated with intermittent cerebrospinal fluid (CSF) diversion. Intracranial pressure (ICP) is monitored and CSF is drained only when the ICP exceeds a threshold dictated by the attending physician.

Primary Outcome Measures :
  1. Cerebral Artery Vasospasm [ Time Frame: 14 days ]
    Cerebral artery vasospasm is defined as transcranial doppler mean velocity greater than 120 or angiographic vasospasm determined by cerebral angiogram.

Secondary Outcome Measures :
  1. External Ventricular Drain (EVD) Complications [ Time Frame: 14 Days ]
    External ventricular drain complications are defined as ventriculitis, shunt dependency, ventricular catheter obstruction requiring manipulation, or removal by the patient.

  2. Cerebrospinal Fluid (CSF) Output Per Day [ Time Frame: 14 Days ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Subarachnoid hemorrhage

Inclusion Criteria:

  • Clinical diagnosis of subarachnoid hemorrhage
  • Age 18 years or older
  • Ventriculostomy in situ

Exclusion Criteria:

  • Prisoners
  • Glasgow coma score = 3

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00787020

United States, North Carolina
Duke University
Durham, North Carolina, United States, 27710
Sponsors and Collaborators
Duke University
Principal Investigator: DaiWai M Olson, PhD RN Duke University

Publications of Results:
Responsible Party: Duke University Identifier: NCT00787020     History of Changes
Other Study ID Numbers: Pro00005900
First Posted: November 7, 2008    Key Record Dates
Results First Posted: December 17, 2010
Last Update Posted: November 3, 2015
Last Verified: March 2011

Keywords provided by Duke University:
Cerebrospinal Fluid
Subarachnoid hemorrhage
Human Subjects

Additional relevant MeSH terms:
Subarachnoid Hemorrhage
Pathologic Processes
Intracranial Hemorrhages
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases