Tight End-tidal Gas Control During Anesthesia to Decrease Postoperative Delirium Anesthetic Management

NCT04406350 | Unknown

• 1 other identifier: AOC2019-6
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

Respiratory end-tidal gas control is a fundamental of anesthetic management. The range of end-tidal (ET) O2 and CO2 during the conduct of anesthesia is far outside that found in the awake state. Recent work has indicated that alterations in end-tidal gases may influence the incidence of postoperative delirium (POD). This study will examine the feasibility of tight end-tidal gas control during anesthesia to decrease the incidence of POD.

Conditions

Post-Operative Confusion; Delirium; Anesthesia Complication

Keywords

anesthesia; post-operative delirium; MRI; BOLD imaging; psychometric testing

Outcome Measures

Primary Outcomes (1)

• Incidence of post-operative delirium

  Incidence of delirium will be assessed in the Pilot Study Group as measured by the number of positive Confusion Assessment Method (CAM) and CAM-S or CAM for intensive care unit (CAM-ICU) scores, coupled with Chart Review.

  5 days

Secondary Outcomes (1)

• Length of Hospital stay

  Time (days) from admission to discharge from hospital (or through study completion at one year)

Study Arms (1)

Study group - MRI CO2 and O2 stress test

EXPERIMENTAL

Pilot Study of Feasibility of tight control of end-tidal respiratory gases during conduct of anesthesia

Procedure: Intraoperative tight control of respiratory end-tidal gases

Interventions

Intraoperative tight control of respiratory end-tidal gases PROCEDURE

Control of ET CO2 and ET O2 during conduct of anesthesia.

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+)

You may qualify if:

• able to provide informed consent
• elective major surgery requiring a minimum stay of 2 days postoperatively
• no contraindication to MRI

You may not qualify if:

• unable to provide informed consent
• CO2 retention with Chronic Obstructive Pulmonary Disease (COPD)
• active congestive heart failure (CHF)
• unable to participate adequately in delirium screening including those who are blind, deaf, illiterate or not fluent English or French
• prior episode of intraoperative awareness

Sponsors & Collaborators

• University of Manitoba: lead

Study Sites (1)

Health Sciences Centre

Winnipeg, Manitoba, R3A 1R9, Canada

Location

Related Publications (6)

• 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 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

• 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 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

• Ellis MJ, Ryner LN, Sobczyk O, Fierstra J, Mikulis DJ, Fisher JA, Duffin J, Mutch WA. Neuroimaging Assessment of Cerebrovascular Reactivity in Concussion: Current Concepts, Methodological Considerations, and Review of the Literature. Front Neurol. 2016 Apr 29;7:61. doi: 10.3389/fneur.2016.00061. eCollection 2016.

  PMID: 27199885 BACKGROUND

MeSH Terms

Conditions

Delirium; Emergence Delirium

Condition Hierarchy (Ancestors)

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

Central Study Contacts

W. Alan C Mutch, MD

CONTACT

2044896549; wacmutch@shaw.ca

Linda Girling, BSc

CONTACT

2047871414; lgirling@exchange.hsc.mb.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A pilot study to determine the feasibility of tight control of end-tidal respiratory gases during the conduct of anesthesia in major surgery.

Study Record Dates

• First Submitted: February 19, 2020
• First Posted: May 28, 2020
• Study Start: June 15, 2020
• Primary Completion: June 30, 2021
• Study Completion: December 31, 2021
• Last Updated: May 28, 2020

Record last verified: 2020-02

Locations

CA (1)