An MRI Study of Post-operative Delirium in Patients Undergoing Major Surgery

NCT02126215 | Unknown

• 1 other identifier: B2013:057-AAA
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (2)

• Blue voxel count/whole brain voxel count

  the number and distribution of 'blue' voxels - those with reversed CO2 and O2 responsiveness to a controlled CO2 and O2 change with blood oxygen level dependent (BOLD) MRI.

  Baseline

• Incidence of post-op delirium

  the incidence and severity of post-op delirium using the cognitive assessment method - intensive care unit (CAM-ICU) scoring approach twice a day.

  Post-op out to discharge or maximum of 2 weeks post-surgery

Secondary Outcomes (3)

• Length of Stay (LOS) in hospital

  post-operatively to 2 weeks

• Stroke

  Post-op until time of discharge up to 2 weeks

• Intra-operative blood pressure

  Intra-operative

Other Outcomes (1)

• Pre-op test for post-operative delirium (POD)

  up to 2 weeks

Study Arms (1)

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.

Procedure: MRI CO2 and O2 stress testing

Interventions

MRI CO2 and O2 stress testing PROCEDURE

Pre and post operatively

Study group - MRI CO2 and O2 stress test

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients scheduled to undergo major surgery.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Manitoba: lead

Study Sites (1)

Kleysen Institute for Advanced Medicine - Health Sciences Centre

Winnipeg, Manitoba, R3E 0Z2, Canada

RECRUITING

Related Publications (6)

• Mutch WA, Mandell DM, Fisher JA, Mikulis DJ, Crawley AP, Pucci O, Duffin J. Approaches to brain stress testing: BOLD magnetic resonance imaging with computer-controlled delivery of carbon dioxide. PLoS One. 2012;7(11):e47443. doi: 10.1371/journal.pone.0047443. Epub 2012 Nov 5.

  PMID: 23139743 BACKGROUND

• Mutch WAC, El-Gabalawy R. Anesthesia and postoperative delirium: the agent is a strawman - the problem is CO2. Can J Anaesth. 2017 Jun;64(6):678-680. doi: 10.1007/s12630-017-0859-3. Epub 2017 Mar 10. No abstract available.

  PMID: 28283991 BACKGROUND

• El-Gabalawy R, Patel R, Kilborn K, Blaney C, Hoban C, Ryner L, Funk D, Legaspi R, Fisher JA, Duffin J, Mikulis DJ, Mutch WAC. A Novel Stress-Diathesis Model to Predict Risk of Post-operative Delirium: Implications for Intra-operative Management. Front Aging Neurosci. 2017 Aug 18;9:274. doi: 10.3389/fnagi.2017.00274. eCollection 2017.

  PMID: 28868035 BACKGROUND

• Mutch WAC, El-Gabalawy RM, Graham MR. Postoperative Delirium, Learning, and Anesthetic Neurotoxicity: Some Perspectives and Directions. Front Neurol. 2018 Mar 20;9:177. doi: 10.3389/fneur.2018.00177. eCollection 2018.

  PMID: 29615969 BACKGROUND

• Mutch WAC, El-Gabalawy R, Girling L, Kilborn K, Jacobsohn E. End-Tidal Hypocapnia Under Anesthesia Predicts Postoperative Delirium. Front Neurol. 2018 Aug 17;9:678. doi: 10.3389/fneur.2018.00678. eCollection 2018.

  PMID: 30174647 BACKGROUND

• Mutch WAC, El-Gabalawy R, Ryner L, Puig J, Essig M, Kilborn K, Fidler K, Graham MR. Brain BOLD MRI O2 and CO2 stress testing: implications for perioperative neurocognitive disorder following surgery. Crit Care. 2020 Mar 4;24(1):76. doi: 10.1186/s13054-020-2800-3.

  PMID: 32131878 DERIVED

MeSH Terms

Conditions

Emergence Delirium; Aortic Aneurysm, Abdominal

Condition Hierarchy (Ancestors)

Delirium; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Neurocognitive Disorders; Mental Disorders; Aortic Aneurysm; Aneurysm; Vascular Diseases; Cardiovascular Diseases; Aortic Diseases

Study Officials

• W. Alan Mutch, MD

  University of Manitoba

  PRINCIPAL INVESTIGATOR

Central Study Contacts

W. Alan Mutch, MD

CONTACT

2047893731; amutch@cc.umanitoba.ca

Linda Girling

CONTACT

2047871414; lgirling@hsc.mb.ca

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 22, 2014
• First Posted: April 29, 2014
• Study Start: July 1, 2014
• Primary Completion: July 1, 2020
• Study Completion: July 1, 2020
• Last Updated: July 11, 2019

Record last verified: 2019-07

Locations

CA (1)