Prevention of Postoperative Delirium in Elderly Patients

Postoperative Delirium Clinical Trial

— PODproject  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06248684
• Other study ID #: Postoperative delirium project
• Status: Not yet recruiting
• Phase: N/A
• Start date: February 6, 2024
• Est. completion date: December 31, 2026

Study information

• Verified date: January 2024
• Source: Technical University of Munich
• Contact: Gerhard Prof. Dr. med. Schneider, MD
• Phone: +49-89-41404291
• Email: AINS[@]mri.tum.de
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 15000
• Est. completion date: December 31, 2026
• Est. primary completion date: June 30, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Delirium
• Emergence Delirium
• Postoperative Delirium

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Technical University of Munich

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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