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Clinical Trials/NCT06510140
NCT06510140
Recruiting
Not Applicable

Interest in Combining Intraoperative ElectroEncephaloGram (EEG) With Assessment of Frailty to Predict Postoperative Delirium in Patients Aged >75 Years Undergoing Major Non-cardiac Surgery

Centre Hospitalier Universitaire de Saint Etienne1 site in 1 country55 target enrollmentMay 15, 2024

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Post-operative Delirium
Sponsor
Centre Hospitalier Universitaire de Saint Etienne
Enrollment
55
Locations
1
Primary Endpoint
Onset of an early Post-operative delirium (POD)
Status
Recruiting
Last Updated
last year

Overview

Brief Summary

Post-operative delirium (POD) is known to be independently associated with pre-operative frailty, pre-operative cognitive status and per-operative ElectroEncephaloGram (EEG). However, no study has focused on the impact of these pre- and peri-operative outcomes on the prediction of Post-operative delirium (POD). Therefore, this study has been designed to assess the performance of a new score that includes pre-operative frailty, and per-operative ElectroEncephaloGram (EEG) in predicting post-operative delirium.

Registry
clinicaltrials.gov
Start Date
May 15, 2024
End Date
October 2025
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • Patients of 75 yo or more undergoing a major non-cardiac surgery

Exclusion Criteria

  • Patients of less than 75 yo
  • Cardiac surgery
  • Minor surgery
  • Opposition to the study protocol
  • Presence of a delirium prior to the surgery

Outcomes

Primary Outcomes

Onset of an early Post-operative delirium (POD)

Time Frame: Hour : 48

Investigation of an early Post-operative delirium (POD), with Confusion Assessment Method (CAM) criteria, 9-question test which assesses the presence, severity and fluctuation of nine clinical features of delirium, on a scale from 0 to 19. Higher scores indicate more severe delirium.

Study Sites (1)

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