Ventriculostomies in SAH: ICP Open or Not?
| Status: | Completed |
|---|---|
| Conditions: | Neurology |
| Therapuetic Areas: | Neurology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/21/2016 |
| Start Date: | November 2008 |
| End Date: | February 2010 |
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.
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.
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.
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.
Inclusion Criteria:
- Clinical diagnosis of subarachnoid hemorrhage
- Age 18 years or older
- Ventriculostomy in situ
Exclusion Criteria:
- Prisoners
- Glasgow coma score = 3
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