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NCT03285971 · ClinicalTrials.gov registry record · Early Phase 1
Real-Time Decision Support for Improving Intraoperative Cerebral Perfusion Pressure
A Early Phase 1 study, sponsored by University of Michigan.
- Completed
- Registry status
- Early Phase 1
- Development phase
- 53
- Enrollment target
NCT03285971 is a Early Phase 1 study that has completed, run by University of Michigan. The registered enrollment target is 53 participants.
The verdict
NCT03285971, a Early Phase 1 study, has completed, sponsored by University of Michigan.
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 53 participants
- Enrollment target
Study 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.
Interventions
- OTHER Electronic CPP pager alert
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 53 participants |
| Start Date | 2017-09-25 |
| Est. Completion | 2021-12-11 |
| Phase | Early Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03285971
The ClinicalTrials.gov registry entry for NCT03285971 describes a study currently listed as completed, categorized as Early Phase 1. The registered enrollment target is 53 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Michigan, which has 1,327 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Electronic CPP pager alert is the first listed.
NCT03285971 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03285971 about?
NCT03285971 is a clinical study titled "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...
What is the current status of trial NCT03285971?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 53 participants. The study started on 2017-09-25. Estimated completion is 2021-12-11.
What interventions are being tested in trial NCT03285971?
The interventions under investigation include: Electronic CPP pager alert (OTHER).
Who is sponsoring clinical trial NCT03285971?
This trial is sponsored by University of Michigan, which has 1,327 total clinical trials registered on ClinicalTrials.gov.
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