Prevention of Postoperative Delirium in Elderly Patients (PODproject)

Prevention of Postoperative Delirium in the Care of Elderly Patients. A Monocentric, Prospective Intervention Study

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Postoperative Delirium
• Intervention / Treatment: Other: standardized prevention and therapy measures

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.

• Study Type: Interventional
• Enrollment (Estimated): 15000
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Gerhard Prof. Dr. med. Schneider, MD; Phone Number: +49-89-41404291; Email: AINS@mri.tum.de
• Study Contact Backup: Name: Stefanie PD Dr. med. Pilge, MD; Phone Number: +49-89-41404291; Email: AINS@mri.tum.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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.	Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of postoperative delirium	Patients are examined once per shift for the described duration postoperatively using validated tests for delirium (CAM-ICU or 3D-CAM). Delirium testing is supplemented by pain assessment using the numerical rating scale (NRS).	for three days postoperatively and if the patient is delirium positive on the last day for the period until he is delirium negative or discharged from inpatient care, up to the day 90 visit at the latest

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
duration of postoperative delirium	Patients are examined once per shift for the described duration postoperatively using validated tests for delirium (CAM-ICU or 3D-CAM). Delirium testing is supplemented by pain assessment using the numerical rating scale (NRS).	for three days postoperatively and if the patient has delirium on the last day for the period until he is delirium negative or discharged from inpatient care, up to the day 90 visit at the latest
Severity of the postoperative delirium	Patients are examined once per shift for the described duration postoperatively using validated tests for delirium severity (CAM-ICU or 3D-CAM). Delirium testing is supplemented by pain assessment using the numerical rating scale (NRS).	for three days postoperatively and if the patient has delirium on the last day for the period until he is delirium negative or discharged from inpatient care, up to the day 90 visit at the latest
Which parameters and tests detect patients at risk for postoperative delirium?	analysis of the preoperative risk assessment, perioperative clinical parameters and postoperative delirium screening.	From the time of premedication until three days postoperatively
Can baseline and intraoperative EEG parameters be used to identify patients at risk? Does intraoperative burst suppression EEG represent a risk factor for delirium?	Analysis of EEG data recorded immediately before induction of anesthesia and during surgery.	From the patient's arrival in the operating room to three days postoperatively
When is the diagnosis of postoperative delirium most commonly made?	Patients are examined once per shift for the described duration postoperatively using validated tests for delirium (CAM-ICU or 3D-CAM). Delirium testing is supplemented by pain assessment using the numerical rating scale (NRS).	for three days postoperative
The implementation of a delirium management protocol during the intervention period serves to improve the three-month outcome of patients at risk in terms of maintaining their autonomy or daily living skills.	Patients are asked about their daily living skills by telephone three months after their surgical procedure.	One-time interview three months postoperatively
Implementation of a delirium management protocol reduces the length of hospital stay of risk patients	The length of inpatient stay of patients before and after implementation of standardized care is evaluated	from the date of hospitalisation to the date of discharge from hospital, up to the day 90 visit at the latest
Implementation of a delirium management protocol reduces three-month mortality in high-risk patients	Three-month mortality of patients before and after implementation of standardized care is evaluated	Query of the patients' death data three months postoperatively

Collaborators and Investigators

• Sponsor: Technical University of Munich
• Investigators: Principal Investigator: Gerhard Prof. Dr. med. Schneider, MD, clinic for anesthesiology and intensive care, Klinikum rechts der Isar, Technical University Munich

Study record dates

Study Major Dates

• Study Start (Estimated): February 6, 2024
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: October 1, 2023
• First Submitted That Met QC Criteria: February 5, 2024
• First Posted (Actual): February 8, 2024

Study Record Updates

• Last Update Posted (Actual): February 8, 2024
• Last Update Submitted That Met QC Criteria: February 5, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: cognitive tests; post operative delirium; delirium, prevention and control; delirium, risk factors; delirium, risk assessment; Baseline-EEG; EEG, intraoperative
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Nervous System Diseases; Postoperative Complications; Neurologic Manifestations; Confusion; Neurobehavioral Manifestations; Neurocognitive Disorders; Delirium; Emergence Delirium
• Other Study ID Numbers: Postoperative delirium project

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