Postoperative DeliriumPODprojectNCT06248684
Prevention of Postoperative Delirium in Elderly Patients
A study testing standardized prevention and therapy measures in people with Postoperative Delirium, run by Technical University of Munich.
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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Postoperative Delirium
- What is being tested?
- standardized prevention and therapy measures
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15,000 participants
- Where
- No sites listed yet
- Study dates
- 6 Feb 2024to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- >= 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
Who cannot join
- Foreign language patients without interpreter
- non-consenting patients without a legal representative
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
Read the 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
- Being tested
- standardized prevention and therapy measures
- Keywords
- delirium, prevention and control, post operative delirium, delirium, risk factors, delirium, risk assessment, Baseline-EEG, cognitive tests, EEG, intraoperative
- Medical subject headings
- Emergence Delirium, Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
standardized prevention and therapy measuresOther
Patients from the age of 65 years with an additional risk factor for postoperative delirium are assigned to a multidimensional standardized perioperative care protocol.
| Study group | Role | What they receive |
|---|---|---|
| prevention group | Other | 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. Receives: Other: standardized prevention and therapy measures |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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 (8)
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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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
Measured: 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
Measured: Query of the patients' death data three months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2024
- Study start6 Feb 2024 (estimated)
- Primary completion30 Jun 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative DeliriumStudies of the same condition, open and under way.
- More trials run by Technical University of MunichThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Technical University of Munich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gerhard Prof. Dr. med. Schneider, MD, Principal investigator, clinic for anesthesiology and intensive care, Klinikum rechts der Isar, Technical University Munich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06248684
- Sponsor's protocol ID
- Postoperative delirium project
- Acronym
- PODproject
- Status last verified
- Jan 2024
- First submitted
- 1 Oct 2023
- Last updated
- 8 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention of Postoperative Delirium in the Care of Elderly Patients. A Monocentric, Prospective Intervention Study
- ClinicalTrials.gov ID
- NCT06248684
- Acronym / sponsor ID
- PODproject / Postoperative delirium project
- Conditions
- Postoperative Delirium
- Keywords
- delirium, prevention and control, post operative delirium, delirium, risk factors, delirium, risk assessment, Baseline-EEG, cognitive tests, EEG, intraoperative
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 15,000 participants (estimated)
- Lead sponsor
- Technical University of MunichUniversity, hospital or other
- Study start
- 6 Feb 2024 (estimated)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 8 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| prevention group | Other | Other: standardized prevention and therapy measurespatients receive standardized perioperative care using Standard Operating Procedures (SOPs) in accordance with the guidelines of the professional societies for the prevention of postoperative delirium. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- >= 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
Key exclusion criteria (2 listed)
- Foreign language patients without interpreter
- non-consenting patients without a legal representative
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| standardized prevention and therapy measuresPatients from the age of 65 years with an additional risk factor for postoperative delirium are assigned to a multidimensional standardized perioperative care protocol. | Other | prevention group |
Primary outcome
Incidence of postoperative delirium
Time frame: 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
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).
8 secondary outcomes
duration of postoperative delirium
Time frame: 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
Time frame: 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?
Time frame: 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?
Time frame: From the patient's arrival in the operating room to three days postoperatively
When is the diagnosis of postoperative delirium most commonly made?
Time frame: 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.
Time frame: One-time interview three months postoperatively
Implementation of a delirium management protocol reduces the length of hospital stay of risk patients
Time frame: 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
Time frame: Query of the patients' death data three months postoperatively
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Gerhard Prof. Dr. med. Schneider, MD principal investigator
clinic for anesthesiology and intensive care, Klinikum rechts der Isar, Technical University Munich
Questions about this trial
What is this clinical trial studying?
A study testing standardized prevention and therapy measures in people with Postoperative Delirium, run by Technical University of Munich.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 8 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Gerhard Prof. Dr. med. Schneider, MD (+49-89-41404291, AINS@mri.tum.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of postoperative delirium (time frame: 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2024.