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Completed

NCT Number: NCT03285971

Real-Time Decision Support for Improving Intraoperative Cerebral Perfusion Pressure

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.

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Key information

Conditions

Cerebral Hypoperfusion

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Michigan Medicine - University of Michigan

Ann Arbor, Michigan, 48109, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Electronic CPP pager alert

Other

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

Other names: Alerting system

Primary outcomes

  1. Mean Cerebral Perfusion Pressure (CPP, mmHg)

    Time frame: Assessed intraoperatively for the duration of the CPP monitoring period

Secondary outcomes

  1. Mortality (incidence, %)

    Time frame: Within 30 days of surgery

  2. Postoperative Stroke (incidence, %)

    Time frame: Within 30 days of surgery

  3. Myocardial Infarction (incidence, %)

    Time frame: Within 30 days of surgery

  4. Congestive Heart Failure (incidence, %)

    Time frame: Within 30 days of surgery

  5. Cardiac Dysrythmias (incidence, %)

    Time frame: Within 30 days of surgery

    New onset of any of the following: supraventricular tachycardia, atrial fibrillation, atrial flutter, ventricular fibrilation, ventricular tachycardia, heart block requiring pacing

  6. Acute Respiratory Distress Syndrome, ARDS (incidence, %)

    Time frame: Within 30 days of surgery

  7. Acute Kidney Injury, AKI (incidence, %)

    Time frame: Within 30 days of surgery

Other outcomes

  1. Area Under the Curve (AUC) 60 mmHg (min*mmHg)

    Time frame: Assessed intraoperatively for the duration of the CPP monitoring period

  2. Time Spent with CPP <60 mmHg

    Time frame: Assessed intraoperatively for the duration of the CPP monitoring period

  3. Volume of Cerebrospinal Fluid (CSF) Drained Intraoperatively (mL)

    Time frame: Assessed intraoperatively for the duration of the CPP monitoring period

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Registry information

Important dates

Study start
2017
Primary completion
2021
Study completion
2021
First posted
Sep 18, 2017
Registry last updated
Oct 12, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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