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Real-Time Decision Support for Improving Intraoperative Cerebral Perfusion Pressure

Real-Time Decision Support for Improving Intraoperative Cerebral Perfusion Pressure

Status
Completed
Phases
Early Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03285971
Enrollment
53
Registered
2017-09-18
Start date
2017-09-25
Completion date
2021-12-11
Last updated
2022-10-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cerebral Hypoperfusion

Brief summary

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.

Detailed description

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.

Interventions

OTHERElectronic CPP pager alert

Anesthesia providers will receive a pager alert when CPP decreases beow 60 mmHG (median value over 5-minute epochs)

Sponsors

University of Michigan
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Mean Cerebral Perfusion Pressure (CPP, mmHg)Assessed intraoperatively for the duration of the CPP monitoring period

Secondary

MeasureTime frameDescription
Myocardial Infarction (incidence, %)Within 30 days of surgery
Cardiac Dysrythmias (incidence, %)Within 30 days of surgeryNew onset of any of the following: supraventricular tachycardia, atrial fibrillation, atrial flutter, ventricular fibrilation, ventricular tachycardia, heart block requiring pacing
Acute Respiratory Distress Syndrome, ARDS (incidence, %)Within 30 days of surgery
Acute Kidney Injury, AKI (incidence, %)Within 30 days of surgery
Mortality (incidence, %)Within 30 days of surgery
Postoperative Stroke (incidence, %)Within 30 days of surgery
Congestive Heart Failure (incidence, %)Within 30 days of surgery

Other

MeasureTime frame
Volume of Cerebrospinal Fluid (CSF) Drained Intraoperatively (mL)Assessed intraoperatively for the duration of the CPP monitoring period
Area Under the Curve (AUC) 60 mmHg (min*mmHg)Assessed intraoperatively for the duration of the CPP monitoring period
Time Spent with CPP <60 mmHgAssessed intraoperatively for the duration of the CPP monitoring period

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026