Recruiting

Observational Study

Sponsor:

University of Manitoba

Code:

NCT02126215

Conditions

Postoperative Delirium

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

MRI CO2 and O2 stress testing

Study Details

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 $6.9 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 hospital's 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.

Conditions

Postoperative Delirium

Study ID

NCT02126215

Start date

Jul, 2014

Status verified date

Jul, 2019

Completion date

Jul, 2020

Anticipated

Primary completion date

Jul, 2020

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • major surgery
  • able to tolerate CO2 and O2 stress test

Exclusion Criteria:

  • diagnosed dementia
  • unable to have MRI
  • excessive claustrophobia
  • unstable angina, recent myocardial infarction (MI)
  • chronic obstructive pulmonary disease (COPD)

Study Design

Enrollment

20 participants

Anticipated

Interventions and Outcome Measures

Arms

Study group - MRI CO2 and O2 stress test

This is a pilot study to assess feasibility of using MRI CO2 and O2 stress testing to predict POD.

Interventions

MRI CO2 and O2 stress testing

Pre and post operatively

Primary outcome measure

  • Blue voxel count/whole brain voxel count [ Time Frame: Baseline ]
  • Incidence of post-op delirium [ Time Frame: Post-op out to discharge or maximum of 2 weeks post-surgery ]

Central Contacts and Locations

Central contacts

Locations

Kleysen Institute for Advanced Medicine - Health Sciences Centre

Recruiting

Winnipeg, Manitoba, Canada, R3E 0Z2

Contacts

Principal Investigator:

W. Alan Mutch, MD

More Information

Sponsor

University of Manitoba

Last update posted

Jul 11, 2019

Last verified

Jul, 2019

Keywords

  • magnetic resonance imaging
  • carbon dioxide
  • abdominal aortic aneurysm
  • post-op delirium

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Manitoba on 2019-07-11.