CI

At a glance

ClinicalIndex Comparison Record
Early Ph 1Completed· 53 enrolled
Drug / intervention
Electronic CPP pager alertother
Likely dose
Not stated in record
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Search/NCT03285971
NCT03285971Early Ph 1Completed

Real-Time Decision Support for Improving Intraoperative Cerebral Perfusion Pressure

University of Michigan·interventional·Posted Sep 18, 2017·Updated Oct 12, 2022

In Brief

A Early Phase 1 clinical trial evaluating Electronic CPP pager alert for Cerebral Hypoperfusion. Completed, enrolled 53 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Early Ph 1CompletedFinished
201820192020202120222023202420252026
First PostedSep 18, 2017
Enrollment StartSep 25, 2017
Primary CompletionDec 11, 2021
TodayJul 2, 2026
Enrollment to primary: 4.2 yearsPosted 8.8 years ago

Interventions

Electronic CPP pager alertother

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