Real-Time Decision Support for Improving Intraoperative Cerebral Perfusion Pressure
| Status: | Recruiting |
|---|---|
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 5/6/2018 |
| Start Date: | September 25, 2017 |
| End Date: | December 31, 2020 |
| Contact: | Phillip Vlisides, MD |
| Email: | pvliside@med.umich.edu |
| Phone: | (734) 936-4280 |
Across broad surgical populations, cerebral hypoperfusion is associated with increased
mortality, stroke, brain cellular injury, and poor functional outcomes. Based on available
evidence, The Brain Trauma Foundation recommends that cerebral perfusion pressure (CPP) be
maintained greater than 60 mmHg in high-risk settings to minimize risk of cerebral ischemia.
Though several lines of investigation have focused on optimal cerebrovascular management in
the intensive care unit and cardiac surgery settings, much less focus has been placed on
cerebrovascular management during non-cardiac surgery.
Preliminary data indicate that intraoperative CPP routinely falls below 60 mmHg in
neurosurgical and trauma surgery settings, though the relationship between reduced
intraoperative CPP and outcomes remains unclear. Furthermore, effective methods by which low
intraoperative CPP could be prevented have not been thoroughly investigated, which represents
the first required step prior to studying the relationship between intraoperative CPP and
clinical outcomes. Thus, the aim of this study is to evaluate the efficacy of an automated
algorithm that alerts clinicians to a decrease in CPP below 60 mmHg. This study tests the
hypothesis that an automated pager alert system (triggered by CPP falling below 60 mmHg) will
increase intraoperative CPP compared to standard of care.
mortality, stroke, brain cellular injury, and poor functional outcomes. Based on available
evidence, The Brain Trauma Foundation recommends that cerebral perfusion pressure (CPP) be
maintained greater than 60 mmHg in high-risk settings to minimize risk of cerebral ischemia.
Though several lines of investigation have focused on optimal cerebrovascular management in
the intensive care unit and cardiac surgery settings, much less focus has been placed on
cerebrovascular management during non-cardiac surgery.
Preliminary data indicate that intraoperative CPP routinely falls below 60 mmHg in
neurosurgical and trauma surgery settings, though the relationship between reduced
intraoperative CPP and outcomes remains unclear. Furthermore, effective methods by which low
intraoperative CPP could be prevented have not been thoroughly investigated, which represents
the first required step prior to studying the relationship between intraoperative CPP and
clinical outcomes. Thus, the aim of this study is to evaluate the efficacy of an automated
algorithm that alerts clinicians to a decrease in CPP below 60 mmHg. This study tests the
hypothesis that an automated pager alert system (triggered by CPP falling below 60 mmHg) will
increase intraoperative CPP compared to standard of care.
This will be a single-center study taking place at the University of Michigan Health System,
Ann Arbor, MI. The study has been approved by the University of Michigan Medical School
Institutional Review Board (IRBMED).
Automated pager alert protocols have been previously published from the investigators'
department, and this alerting system is used for operational purposes on a daily basis.
Surgical patients will be automatically screened using a designed script from the anesthesia
information management system (Centricity, Wishahaka, WI).
The script will screen for active surgical patients with intracranial pressure (ICP) data
recording in our hospital's non-cardiac operating rooms. When these data are captured, an
automated enrollment process will occur if the following electronic charting criteria are
met:
- Age ≥ 18 years old
- Case identified as a general anesthetic
- Non-intracranial aneurysm surgery
- Non-pregnant patient
After "anesthetic induction end" time is documented within the case, the alerting system will
turn on after a 10-minute grace period. The alerting system will then retroactively measure
median CPP values over 5-minute epochs, and if median CPP is < 60 mmHg, the following
alphanumeric pager alert will be delivered:
"Patient: LAST NAME, FIRST NAME, OR(N), has a cerebral perfusion pressure < 60 mmHg.
Disregard alert for intracranial aneurysm cases or if patient is pregnant."
This alert will be delivered twice total (if criteria are met). The aim of the pager alerts
will be to relay information regarding cerebral ischemia risk between when CPP decreases
below 60 mmHg. Final clinical decision-making, however, will be left to the anesthesia team.
The pager alerts will not otherwise compel action, and no other recommendations will be made.
Ann Arbor, MI. The study has been approved by the University of Michigan Medical School
Institutional Review Board (IRBMED).
Automated pager alert protocols have been previously published from the investigators'
department, and this alerting system is used for operational purposes on a daily basis.
Surgical patients will be automatically screened using a designed script from the anesthesia
information management system (Centricity, Wishahaka, WI).
The script will screen for active surgical patients with intracranial pressure (ICP) data
recording in our hospital's non-cardiac operating rooms. When these data are captured, an
automated enrollment process will occur if the following electronic charting criteria are
met:
- Age ≥ 18 years old
- Case identified as a general anesthetic
- Non-intracranial aneurysm surgery
- Non-pregnant patient
After "anesthetic induction end" time is documented within the case, the alerting system will
turn on after a 10-minute grace period. The alerting system will then retroactively measure
median CPP values over 5-minute epochs, and if median CPP is < 60 mmHg, the following
alphanumeric pager alert will be delivered:
"Patient: LAST NAME, FIRST NAME, OR(N), has a cerebral perfusion pressure < 60 mmHg.
Disregard alert for intracranial aneurysm cases or if patient is pregnant."
This alert will be delivered twice total (if criteria are met). The aim of the pager alerts
will be to relay information regarding cerebral ischemia risk between when CPP decreases
below 60 mmHg. Final clinical decision-making, however, will be left to the anesthesia team.
The pager alerts will not otherwise compel action, and no other recommendations will be made.
Inclusion Criteria:
- Adult (≥18 years old) surgical patients
- Intracranial pathology requiring intracranial pressure (ICP) monitoring
Exclusion Criteria:
- Intracranial aneurysm surgery
- Cases with pressures monitored from a lumbar drain
- Cardiac surgery cases
- Enrolled in conflicting study
- Pregnancy
We found this trial at
1
site
1150 East Medical Center Drive
Ann Arbor, Michigan 48109
Ann Arbor, Michigan 48109
Phone: 734-936-4280
Click here to add this to my saved trials
