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NCT Number: NCT06510140

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

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.

Recruiting

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Key information

Conditions

Post-operative Delirium Confusion Delirium Emergence Delirium Frailty Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurocognitive Disorders Neurologic Manifestations Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

75 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Centre Hospitalier Universitaire de Saint Etienne

Saint-Etienne, 42055, France

Location status: Recruiting

Location contact

Nory ELHADJENE, MD Jr

PRINCIPAL_INVESTIGATOR

Romane CHAPUIS, resident

SUB_INVESTIGATOR

Serge MOLLIEX, MD PhD

SUB_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Detection of the Post-operative delirium (POD)

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).

Primary outcomes

  1. 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 contacts

Contact information is provided by the study sponsor or research team.

Nory ELHADJENE, MD

CONTACT

[email protected]

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

Romane CHAPUIS, resident

CONTACT

[email protected]

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

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Saint Etienne

Other

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jul 19, 2024
Registry last updated
Jul 22, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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