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

Recruiting

• Conditions: Post-operative Delirium
• Interventions: Behavioral: Detection of the Post-operative delirium (POD)

• Registration Number: NCT06510140
• Lead Sponsor: Centre Hospitalier Universitaire de Saint Etienne

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-05-15
• Status Verified: 2024-07
• Study First Submitted: 2024-07-15
• Study First Submitted QC: 2024-07-18
• Study First Posted: 2024-07-19
• Last Update Submitted: 2024-07-19
• Last Update Posted: 2024-07-22
• Primary Completion: 2025-10
• Study Completion: 2025-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 55

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
No Post-operative delirium (POD) arm (control group)	Detection of the Post-operative delirium (POD)	Patients who do not present a post-operative delirium according to the 3D-CAM within 48h
Post-operative delirium (POD) arm (experimental group)	Detection of the Post-operative delirium (POD)	Patients who present a post-operative delirium according to the 3D-CAM within 48h

Primary Outcome Measures

Name	Time	Method
Onset of an early Post-operative delirium (POD)	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.

Trial Locations

Locations (1)

Centre Hospitalier Universitaire de Saint Etienne; 🇫🇷 Saint Etienne, France