Cerebral Monitoring and Post-operative Delirium and Outcomes

NCT04643834 | Completed

• 1 other identifier: 2020-2667
• Study Type: observational
• Target: 153
• Locations: 1 country
• Sites: 1

Brief Summary

Brain monitoring using near-infrared spectroscopy (NIRS) started in 2002 in the operating room of the Montreal heart Institute (MHI). This was followed by the use of somatic NIRS in 2010, transcranial Doppler in 2015 and processed electroencephalogram (pEEG) using Sedline (Masimo, Irvine CA) in 2017. The introduction of those modalities led to significant change in intraoperative management. The goal of these devices is to improve our ability to detect and predict post-operative complications as well as offering insights on how to prevent them. The current project explores in further detail the impact of the introduction of pEEG in the operating room and in the intensive care unit (ICU) on post-operative delirium.

Conditions

Delirium; Cerebral Desaturation; EEG With Abnormally Slow Frequencies

Keywords

Delirium

Outcome Measures

Primary Outcomes (1)

• Rate of neurological events

  Events will be categorized according to change in oxygen saturation measured by near infra-red spectroscopy and according to changes in pEEG activity evaluated by the patient state index, burst suppression ratio and spectral edge frequency. Events will be categorized based on the following classification: 1. Cerebral desaturation (\>10% from baseline) AND a decrease in pEEG activity (patient state index (PSI) \< 40 and/or burst suppression ratio (BSR) \>0 and/or spectral edge frequency (SEF) \<10) 2. Cerebral desaturation (\>10% from baseline) AND an increase in pEEG activity (PSI ≥ 60, BSR = 0, SEF \> 15) 3. Cerebral desaturation (\>10% from baseline) AND a normal pEEG activity (PSI ≥ 40-60, BSR = 0 and SEF 10-15) 4. Normal cerebral saturation (Cerebral desaturation ≤10% from baseline) AND a decrease in pEEG activity (PSI \< 40, and/or BSR \>0 and/or SEF\<10).

  72 hours

Secondary Outcomes (9)

• Rate of cognitive dysfunction

  72 hours

• Rate of delirium

  72 hours

• Duration of persistent organ dysfunction

  Up to 28 days or until hospital discharge

• Rate of all cause death during hospitalization

  Up to 30 days or until hospital discharge

• Rate of acute kidney injury

  Up to 30 days or until hospital discharge

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Adult patient undergoing cardiac surgery

You may qualify if:

• Male or female patients, age 18 and older, undergoing cardiac surgery with CPB or off pump CABG

You may not qualify if:

• Patient with a critical pre-operative state defined as any of the following: vasopressor requirement, mechanical circulatory support, dialysis, mechanical ventilation, cardiac arrest necessitating resuscitation, aborted sudden death, preoperative cardiac massage, preoperative intra-aortic balloon pump.
• Patient with the diagnosis of delirium at any point before surgery during the current hospitalization
• Emergent surgery
• Surgery under deep hypothermic circulatory arrest

Sponsors & Collaborators

• Montreal Heart Institute: lead
• Masimo Corporation: collaborator

Study Sites (1)

Montreal Heart Institute

Montreal, Quebec, H1T 1C8, Canada

Location

Related Publications (104)

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MeSH Terms

Conditions

Delirium

Condition Hierarchy (Ancestors)

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

Study Officials

• Andre Y Denault, MD, PhD

  Montreal Heart Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 10, 2020
• First Posted: November 25, 2020
• Study Start: November 21, 2019
• Primary Completion: September 30, 2023
• Study Completion: November 30, 2023
• Last Updated: March 19, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)