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

This study has been completed.
Sponsor:
Information provided by:
Duke University
ClinicalTrials.gov Identifier:
NCT00787020
First received: November 6, 2008
Last updated: March 29, 2011
Last verified: March 2011
  Purpose

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
Subarachnoid Hemorrhage

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Ventriculostomies in SAH: ICP Open or Not?

Resource links provided by NLM:


Further study details as provided by Duke University:

Primary Outcome Measures:
  • Cerebral Artery Vasospasm [ Time Frame: 14 days ] [ Designated as safety issue: No ]
    Cerebral artery vasospasm is defined as transcranial doppler mean velocity greater than 120 or angiographic vasospasm determined by cerebral angiogram.


Secondary Outcome Measures:
  • External Ventricular Drain (EVD) Complications [ Time Frame: 14 Days ] [ Designated as safety issue: No ]
    External ventricular drain complications are defined as ventriculitis, shunt dependency, ventricular catheter obstruction requiring manipulation, or removal by the patient.

  • Cerebrospinal Fluid (CSF) Output Per Day [ Time Frame: 14 Days ] [ Designated as safety issue: No ]

Enrollment: 37
Study Start Date: November 2008
Study Completion Date: February 2010
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Subarachnoid hemorrhage

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Prisoners
  • Glasgow coma score = 3
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00787020

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

Publications:
Responsible Party: DaiWai M. Olson, Duke University Medical Center
ClinicalTrials.gov Identifier: NCT00787020     History of Changes
Other Study ID Numbers: Pro00005900
Study First Received: November 6, 2008
Results First Received: October 6, 2010
Last Updated: March 29, 2011
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on October 20, 2014