Ignite Creation Date:
2024-05-06 @ 10:33 AM
Last Modification Date:
2024-10-26 @ 12:31 PM
Study NCT ID:
NCT03285971
Status:
COMPLETED
Last Update Posted:
2022-10-12
First Post:
2017-09-14
Brief Title:
Real-Time Decision Support for Improving Intraoperative Cerebral Perfusion Pressure
Sponsor:
University of Michigan
Organization:
University of Michigan
Study Overview
Official Title:
Real-Time Decision Support for Improving Intraoperative Cerebral Perfusion Pressure
Status:
COMPLETED
Status Verified Date:
2022-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 hospitals 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 ORN 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
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 hospitals 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 ORN 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None