Electroencephalographic Biomarker to Predict Acute Post-operatory Cognitive Dysfunction

NCT04214496 | Completed FDA Device

• 1 other identifier: ID19I10345
• Study Type: observational
• Target: 106
• Locations: 1 country
• Sites: 2

Brief Summary

Acute post-operatory cognitive dysfunction states are one of the most important complications in older patients after surgery. Two acute cognitive dysfunctions have been described: postoperative delirium (PD) and postoperative subsyndromal delirium (PSSD). Patients who develop delirium, both as a complete or incomplete syndrome, have poor long-term outcomes, such as longer length of hospital stay, institutionalization at discharge, and even higher mortality, and consequently, the human and economic costs significantly increase for the health system. Here the research team will use an observational cohort, investigator blinded in two-center with a primary endpoint to validate the relative alpha power ratio as a predictive biomarker of postoperative cognitive dysfunctions.

Conditions

Cognitive Dysfunction; Postoperative Delirium

Keywords

Delirium; Postoperative Delirium; Postoperative Subsyndromal Delirium; Biomarker

Outcome Measures

Primary Outcomes (1)

• Delirium and Subsyndromal Delirium

  Incidence of Delirium and Subsyndromal Delirium in the cohort

  5 Postoperative days

Secondary Outcomes (6)

• Death

  Perioperative period

• Delirium Severity

  5 Postoperative days

• Delirium Duration

  Perioperative period

• Need for Mechanical Ventilation assistance

  Perioperative period

• Reintervention

  Perioperative period

Study Arms (1)

Postoperative Delirium Risk Patients

Preoperative cognitive function testing- EEG monitorization during surgery - Postoperative function testing

Device: Sedline

Interventions

Sedline DEVICE

Intraoperative EEG monitorization

Postoperative Delirium Risk Patients

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients at risk of delirium or subsyndromal delirium after High-risk Surgery will be evaluated in the pre and postoperative period for cognitive dysfunction and the appearance of delirium syndromes. In the intraoperative period, an EEG-based monitorization will be performed using a SedLine (Masimo, CA) Monitor.

You may qualify if:

• Age ≥ 60 years old
• Scheduled for high-risk elective surgery
• Need for at least 3 days of hospital stay
• Surgery performed under general anesthesia
• Written informed consent for participation in the trial

You may not qualify if:

• Patients with preoperative delirium or dementia
• Patients using neuroleptics drug during the past 6 months
• Patients with a history of encephalopathy, psychosis, stroke or brain trauma with neurologic sequels
• The use of ketamine or dexmedetomidine during surgery
• Emergency surgery
• Mechanical ventilation during the 72 after surgery
• Analphabetism
• Patients who do not talk Spanish
• Patients included in another clinical trial

Sponsors & Collaborators

• University of Chile: lead
• Masimo Corporation: collaborator

Study Sites (2)

Hospital Clinico Universidad de Chile

Santiago, 8380456, Chile

Location

Instituto Nacional del Cancer

Santiago, Chile

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood Samples

MeSH Terms

Conditions

Cognitive Dysfunction; Emergence Delirium; Delirium

Condition Hierarchy (Ancestors)

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

Study Officials

• José I. Egaña, M.D./Ph.D.

  University of Chile

  STUDY CHAIR

Study Design

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

Study Record Dates

• First Submitted: December 27, 2019
• First Posted: January 2, 2020
• Study Start: January 4, 2021
• Primary Completion: August 4, 2022
• Study Completion: August 4, 2022
• Last Updated: August 7, 2023

Record last verified: 2023-08

Locations

CL (2)