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

July 19, 2024 updated by: Centre Hospitalier Universitaire de Saint Etienne
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

55

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
      • Saint Etienne, France, 42055
        • Recruiting
        • Centre Hospitalier Universitaire de Saint Etienne
        • Principal Investigator:
          • Nory ELHADJENE, MD Jr
        • Sub-Investigator:
          • Romane CHAPUIS, resident
        • Sub-Investigator:
          • Serge MOLLIEX, MD PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

All patients older than 75 yo, undergoing a major non-cardiac surgery under general anesthesia will be included.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Post-operative delirium (POD) arm (experimental group)
Patients who present a post-operative delirium according to the 3D-CAM within 48h
Behavioral: 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).
No Post-operative delirium (POD) arm (control group)
Patients who do not present a post-operative delirium according to the 3D-CAM within 48h
Behavioral: 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Hour : 48

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire de Saint Etienne

Investigators

  • Principal Investigator: Nory ELHADJENE, MD, CHU Saint-Etienne

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 15, 2024

Primary Completion (Estimated)

October 1, 2025

Study Completion (Estimated)

October 1, 2025

Study Registration Dates

First Submitted

July 15, 2024

First Submitted That Met QC Criteria

July 18, 2024

First Posted (Actual)

July 19, 2024

Study Record Updates

Last Update Posted (Actual)

July 22, 2024

Last Update Submitted That Met QC Criteria

July 19, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRBN482024/CHUSTE

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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