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Electroencephalographic Biomarker to Predict Acute Post-operatory Cognitive Dysfunction

NCT04214496 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 106

Last updated 2023-08-07

No results posted yet for this study

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

Interventions

DEVICE

Sedline

Intraoperative EEG monitorization

Sponsors & Collaborators

  • Masimo Corporation

    collaborator INDUSTRY

  • University of Chile

    lead OTHER

Principal Investigators

  • José I. Egaña, M.D./Ph.D. · University of Chile

Eligibility

Min Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-01-04
Primary Completion
2022-08-04
Completion
2022-08-04
FDA Device
Yes

Countries

  • Chile

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04214496 on ClinicalTrials.gov