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

NCT ID: NCT06510140

Last Updated: 2024-07-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

55 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-05-15

Study Completion Date

2025-10-31

Brief Summary

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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

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Conditions

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Post-operative Delirium

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Post-operative delirium (POD) arm (experimental group)

Patients who present a post-operative delirium according to the 3D-CAM within 48h

Detection of the Post-operative delirium (POD)

Intervention Type BEHAVIORAL

Detection of the early Post-operative delirium (POD) to assess the performance of a new composite score with pre-operative frailty, and per-operative ElectroEncephaloGram (EEG).

No Post-operative delirium (POD) arm (control group)

Patients who do not present a post-operative delirium according to the 3D-CAM within 48h

Detection of the Post-operative delirium (POD)

Intervention Type BEHAVIORAL

Detection of the early Post-operative delirium (POD) to assess the performance of a new composite score with pre-operative frailty, and per-operative ElectroEncephaloGram (EEG).

Interventions

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Detection of the Post-operative delirium (POD)

Detection of the early Post-operative delirium (POD) to assess the performance of a new composite score with pre-operative frailty, and per-operative ElectroEncephaloGram (EEG).

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire de Saint Etienne

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Nory ELHADJENE, MD

Role: PRINCIPAL_INVESTIGATOR

CHU SAINT-ETIENNE

Locations

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Centre Hospitalier Universitaire de Saint Etienne

Saint-Etienne, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Nory ELHADJENE, MD

Role: CONTACT

(0)4 77 12 03 88 ext. +33

Romane CHAPUIS, resident

Role: CONTACT

(0)4 77 12 03 88 ext. +33

Other Identifiers

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IRBN482024/CHUSTE

Identifier Type: -

Identifier Source: org_study_id

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