Ignite Creation Date:
2024-05-06 @ 2:48 AM
Last Modification Date:
2024-10-26 @ 11:23 AM
Study NCT ID:
NCT02126215
Status:
UNKNOWN
Last Update Posted:
2019-07-11
First Post:
2014-04-22
Brief Title:
An MRI Study of Post-operative Delirium in Patients Undergoing Major Surgery
Sponsor:
University of Manitoba
Organization:
University of Manitoba
Study Overview
Official Title:
Blue Cerebrovascular Reactivity CVR Maps as a Marker for Post-operative Delirium POD in Patients Undergoing Abdominal Aortic Aneurysm AAA Surgery A Pilot Study Addition of Other Patients Being Admitted to SSCU After Major Surgery
Status:
UNKNOWN
Status Verified Date:
2019-07
Last Known Status:
RECRUITING
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:
Hypothesis Patients with blue cerebrovascular reactivity CVR regional maps during a hypercapnic CO2 challenge will be at greater risk of developing post-operative delirium POD and stroke following major surgery Blue CVR maps have also been recently documented with an O2 challenge The blue CVR maps will be shown to be predictive of POD and stroke and ultimately represent a diagnostic test for patients at risk These blue CVR maps will enable neurologic risk stratification for patients undergoing major surgery Background Major surgery is associated with a significant risk of postoperative morbidity and mortality POD is a dreaded complication with such anesthesia and surgery The prevalence of delirium after cardiac surgery has been reported to occur in up to 50 of patients Using a definitive diagnostic tool such as the Confusion Assessment Method - Intensive Care Unit CAM-ICU and CAM-S results in the higher proportion reported Delirium is a serious complication that results in prolonged length of stay increased health care costs and higher mortality As much as 69 billion of Medicare hospital expenditures can be attributed to delirium At such a cost better diagnosis and treatment is urgently needed Pre-emptive diagnosis leading to better management of delirium post-operatively is clearly one of the fundamental problems confronting modern anesthesia and peri-operative medicine
Specific Objectives The investigators seek to address a the identity of patients who have the greatest vulnerability to the surgery and b investigate the risks and test appropriate risk mitigations Understanding POD is of immense import to help control a hospitals surgical and critical care costs Patients with neurological consequences including POD often represent a choke point for optimized critical care utilization At the very least improved understanding and a diagnostic test to highlight patients at risk of POD would be most welcome Such an advance would permit rational strategies to limit the problem and allow better designed therapeutic arcs for patients now known to be at risk This is especially important for patients undergoing complicated major surgery and is the focus of this pilot project Tighter control of ET respiratory gases may be indicated for both ET CO2 and ET O2 based on the results of this preliminary study
Specific Objectives The investigators seek to address a the identity of patients who have the greatest vulnerability to the surgery and b investigate the risks and test appropriate risk mitigations Understanding POD is of immense import to help control a hospitals surgical and critical care costs Patients with neurological consequences including POD often represent a choke point for optimized critical care utilization At the very least improved understanding and a diagnostic test to highlight patients at risk of POD would be most welcome Such an advance would permit rational strategies to limit the problem and allow better designed therapeutic arcs for patients now known to be at risk This is especially important for patients undergoing complicated major surgery and is the focus of this pilot project Tighter control of ET respiratory gases may be indicated for both ET CO2 and ET O2 based on the results of this preliminary study
Detailed Description:
Methods Informed witnessed consent will be obtained from all participants Patients will have a Mini Mental State Exam MMSE prior to their MRI studies A battery of neurocognitive tests will be undertaken for each subject prior to surgery This test battery will include PHQ-9 GAD-7 Trails A and WAIS-IV Digit Span Hopkins Verbal Learning Test Revised Reys Complex Figure DKEFS F-A-S CLOX I and II This will take 45-60 minutes Patients will have CVR maps with blood oxygen level dependent BOLD-MRI pulse sequences done with standard RespirAct a computer-controlled gas blender protocols in association with anatomic imaging in a 30 Tesla magnet The clinical care team and patient will be blinded as to the CVR results Patients will have standardized anesthesia and per usual approaches for their major surgery and have standard POD assessment tools CAM-ICU and CAM-S Storage of anesthesia hemodynamics will be to digital data acquisition systems for later collation End-tidal CO2 will be targeted at patient baseline values - 25 mmHg during the surgical procedure and if ventilated for any period post-operatively Inspired O2 will be targeted to 03 - 06 based on pulse oximetry of greater than 95 with adequate arterial oxygenation confirmed by ABG Standard fast-track protocols and admission to the surgical special care unit SSCU will be undertaken to facilitate patient management Any patient with obvious POD post-op delirium or stroke will be managed per usual protocols Multiple CVR maps 650 studies have been done at University Health Network in Toronto As well over 150 studies have been conducted at the Health Sciences Centre at the University of Manitoba in the past 5 years
SignificanceImportance This study has the potential to make an important contribution in the understanding of POD for all surgical procedures and specifically a window into the problem with major surgery A positive study based on our hypothesis can fundamentally change our understanding of cognitive dysfunction after surgery Large follow-up multicentre trials can be constructed based on initial findings from this pilot study if the study bears fruit At the least further elucidation into POD for major surgery is expected with this study tighter control of end-tidal gases may be a consequence of the findings of this study
SignificanceImportance This study has the potential to make an important contribution in the understanding of POD for all surgical procedures and specifically a window into the problem with major surgery A positive study based on our hypothesis can fundamentally change our understanding of cognitive dysfunction after surgery Large follow-up multicentre trials can be constructed based on initial findings from this pilot study if the study bears fruit At the least further elucidation into POD for major surgery is expected with this study tighter control of end-tidal gases may be a consequence of the findings of this study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None