Prevention of Postoperative Delirium in Elderly Patients

NCT ID: NCT06248684

Last Updated: 2024-02-08

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 15000 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-02-06
• Study Completion Date: 2026-12-31

Brief Summary

Prevention of Postoperative Delirium in the care of Elderly Patients. A Monocentric, Prospective Intervention Study With the Question of Whether the Incidence, Length and Severity of Postoperative Delirium Can be Reduced by Implementing a Standardised, Multidimensional Delirium Management Protocol.

Detailed Description

Within the framework of a six-month observation period, the investigators intend to identify risk factors of the patient collective for the development of postoperative delirium. For this purpose, a preoperative risk assessment is performed, which includes cognitive and physical performance as well as premedication and concomitant diseases. Included are patients of at least 65 years of age of defined specialties. Postoperatively, patients who have undergone the assessment are tested for delirium once per shift until the third postoperative day and severity and duration are documented. After completion of the observation period, risk factors favoring the development of postoperative delirium will be identified. In the subsequent intervention period, patients from the age of 65 years with an additional identified risk factor will receive standardized, targeted perioperative care. This includes both adherence to preventive measures in accordance with guidelines and the recommendation of therapeutic measures if a delirium is diagnosed. Through the standardized, interprofessional and interdisciplinary application of the described approach, the investigator aim to reduce the incidence, duration and severity of postoperative delirium. Furthermore, the evaluation of the identification of the weighting of risk factors as well as the identification of risk factors by the tests performed, length of hospital stay, three-month mortality and daily living skills after three months. In addition, a baseline EEG (standardized awake EEG before initiation) is recorded in a subgroup to determine whether patients at risk for delirium can be identified and whether intraoperative EEG parameters support the delirium risk assessment.

Conditions

Postoperative Delirium

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

prevention group

patients receive standardized perioperative care using Standard Operating Procedures (SOPs) in accordance with the guidelines of the professional societies for the prevention of postoperative delirium.

Group Type: OTHER

standardized prevention and therapy measures

Intervention Type: OTHER

Patients from the age of 65 years with an additional risk factor for postoperative delirium are assigned to a multidimensional standardized perioperative care protocol.

Interventions

standardized prevention and therapy measures

Patients from the age of 65 years with an additional risk factor for postoperative delirium are assigned to a multidimensional standardized perioperative care protocol.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• >= 65 Years
• intervention in one of the following departments: general and visceral surgery, urology, vascular surgery, orthopedics, trauma surgery,
• Written consent by patient or legal guardian

Exclusion Criteria

• Foreign language patients without interpreter
• non-consenting patients without a legal representative

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Technical University of Munich

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gerhard Prof. Dr. med. Schneider, MD

Role: PRINCIPAL_INVESTIGATOR

clinic for anesthesiology and intensive care, Klinikum rechts der Isar, Technical University Munich

Central Contacts

Gerhard Prof. Dr. med. Schneider, MD

Role: CONTACT

AINS@mri.tum.de

+49-89-41404291

Stefanie PD Dr. med. Pilge, MD

Role: CONTACT

AINS@mri.tum.de

+49-89-41404291

Other Identifiers

Postoperative delirium project

Identifier Type: -

Identifier Source: org_study_id