Clinical trial NCT06248684: Prevention of Postoperative Delirium in Elderly Patients
Official title: Prevention of Postoperative Delirium in the Care of Elderly Patients. A Monocentric, Prospective Intervention Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Postoperative Delirium
Keywords: delirium, prevention and control
post operative delirium
delirium, risk factors
delirium, risk assessment
Baseline-EEG
cognitive tests
EEG, intraoperative
Lead sponsor: Technical University of Munich
Sponsor class: OTHER
First posted: 2024-02-08
Enrollment: 15000
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Incidence of postoperative delirium
timeFrame: 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 outcomes:
measure: duration of postoperative delirium
timeFrame: 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
measure: Severity of the postoperative delirium
timeFrame: 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
measure: Which parameters and tests detect patients at risk for postoperative delirium?
timeFrame: From the time of premedication until three days postoperatively
measure: Can baseline and intraoperative EEG parameters be used to identify patients at risk? Does intraoperative burst suppression EEG represent a risk factor for delirium?
timeFrame: From the patient's arrival in the operating room to three days postoperatively
measure: When is the diagnosis of postoperative delirium most commonly made?
timeFrame: for three days postoperative
measure: 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.
timeFrame: One-time interview three months postoperatively
measure: Implementation of a delirium management protocol reduces the length of hospital stay of risk patients
timeFrame: from the date of hospitalisation to the date of discharge from hospital, up to the day 90 visit at the latest
measure: Implementation of a delirium management protocol reduces three-month mortality in high-risk patients
timeFrame: Query of the patients' death data three months postoperatively
Other outcomes:
Locations:
Study officials:
affiliation: clinic for anesthesiology and intensive care, Klinikum rechts der Isar, Technical University Munich
name: Gerhard Prof. Dr. med. Schneider, MD
role: PRINCIPAL_INVESTIGATOR
References: