Postoperative DeliriumPODMASNCT04460716
Predictors for Postoperative Delirium After Major Noncardiac Surgery in Adults
An observational study of Postoperative Delirium, run by University Hospital, Basel, Switzerland.
Trial summary
This research project is an observational cohort study by retrospective chart review of patients that underwent major noncardiac surgery at University Hospital Basel, Switzerland, in the years 2011-2015. The PODMAS study aims to identify risk factors for POD in a general surgical population. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Delirium
- What is being tested?
- Major noncardiac surgery
- Type of treatment
- Surgery or procedure
- How many people
- 5,000 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2011to 31 Dec 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients who underwent major noncardiac surgery at the University Hospital Basel during the years 2011-2015.
Who may be able to join
- All patients who underwent major noncardiac surgery at the University Hospital Basel during the years 2011-2015.
Who cannot join
- Patients that died during the operation or one day after surgery.
About this study
This research project is an observational cohort study by retrospective chart review of patients that underwent major noncardiac surgery at University Hospital Basel, Switzerland, in the years 2011-2015. The PODMAS study aims to identify risk factors for POD in a general surgical population.
Read the detailed description
The Diagnostic and Statistical Manual of Mental Disorders, 5th ed. (DSM-5) describes delirium as a "disturbance in attention (i.e., reduced ability to direct, focus, sustain, and shift attention) and awareness (reduced orientation to the environment)". In addition, a "disturbance in cognition (e.g., memory deficit, disorientation, language, visuospatial ability, or perception)" occurs. The deficits cannot be explained by other neurocognitive disorders.
Delirium develops within hours to a few days and can fluctuate in severity during the day. Acute delirium lasts a few hours or days, whereas persistent delirium lasts for weeks or months. In a hospital setting, delirium hardly ever lasts longer than a week but some symptoms can persist for months after the patient was discharged.
According to the International Statistical Classification of Diseases and Related Health Problems, 10th rev. (ICD-10), delirium is a pathologic brain disorder, which consists of a disturbance in consciousness, attention, perception, memory, psychomotor functions, emotional stability, and circadian rhythm. The severity can range from mild to very severe POD occurs in connection with a surgical procedure within the first four days after an intervention. 10-70% of all surgical patients above the age of 65 years are affected.
Delirium is not only a burden to the patient and their family by increasing functional and cognitive damages, and increasing mortality, it has a high impact on the economy, as well. A patient with delirium has a longer length of hospital stay, more complications, and often requires long-term care after being discharged from the hospital. All these aspects show the need for prevention of delirium.
There are various preoperative risk factors that influence the development of POD. Advanced age, preexisting cognitive impairment, depression and other psychopathologic symptoms, intake of psychotropic substances, sensory impairment like decrease in visual or auditory perception, impairment in daily life activities, dehydration, malnutrition, metabolic dysfunctions, urinary catheters, severe diseases and different comorbidities such as chronic cardiac insufficiency, atrial fibrillation, or previous history of stroke or infections favor the development of delirium.
The incidence of POD after major noncardiac surgery and the burden to patients and healthcare systems in general is high.
This research project is an observational cohort study by retrospective chart review of patients that underwent major noncardiac surgery at University Hospital Basel, Switzerland, in the years 2011-2015. The PODMAS study aims to identify risk factors for POD in a general surgical population.
- Conditions
- Postoperative Delirium
- Being tested
- Major noncardiac surgery
- Medical subject headings
- Emergence Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Major noncardiac surgeryProcedure or surgery
Vascular, thoracic, visceral, orthopedic, gynecologic, urologic, ENT, maxillo-facial, plastic and reconstructive surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of postoperative delirium
Incidence of postoperative delirium assessed by a validated delirium measurement tool (CAM, 3D-CAM, CAM-ICU, ICDSC, MDAS, GAR, DOSS, Nu-DESC, DRS-R-98, and/or patient chart review)
Measured: Daily assessment of postoperative delirium from postoperative day 1 up to postoperative day 30 or hospital discharge, whichever comes first
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2020
- Study start1 Jan 2011
- Primary completion31 Dec 2015
- Study completion31 Dec 2015
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 University Hospital, Basel, SwitzerlandThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 5,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nicolai Goettel, University Hospital, Basel, Switzerland
- Investigators
- Nicolai Goettel, MD, Principal investigator, University Hospital, Basel, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04460716
- Sponsor's protocol ID
- PODMAS
- Acronym
- PODMAS
- Status last verified
- Jul 2020
- First submitted
- 25 Jun 2020
- Last updated
- 7 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictors for Postoperative Delirium After Major Noncardiac Surgery in Adults
- ClinicalTrials.gov ID
- NCT04460716
- Acronym / sponsor ID
- PODMAS / PODMAS
- Conditions
- Postoperative Delirium
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 5,000 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- 1 Jan 2011 (actual)
- Primary completion
- 31 Dec 2015 (actual)
- Study completion
- 31 Dec 2015 (actual)
- First posted
- 7 Jul 2020 (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.
This research project is an observational cohort study by retrospective chart review of patients that underwent major noncardiac surgery at University Hospital Basel, Switzerland, in the years 2011-2015. The PODMAS study aims to identify risk factors for POD in a general surgical population.
Detailed description
The Diagnostic and Statistical Manual of Mental Disorders, 5th ed. (DSM-5) describes delirium as a "disturbance in attention (i.e., reduced ability to direct, focus, sustain, and shift attention) and awareness (reduced orientation to the environment)". In addition, a "disturbance in cognition (e.g., memory deficit, disorientation, language, visuospatial ability, or perception)" occurs. The deficits cannot be explained by other neurocognitive disorders.
Delirium develops within hours to a few days and can fluctuate in severity during the day. Acute delirium lasts a few hours or days, whereas persistent delirium lasts for weeks or months. In a hospital setting, delirium hardly ever lasts longer than a week but some symptoms can persist for months after the patient was discharged.
According to the International Statistical Classification of Diseases and Related Health Problems, 10th rev. (ICD-10), delirium is a pathologic brain disorder, which consists of a disturbance in consciousness, attention, perception, memory, psychomotor functions, emotional stability, and circadian rhythm. The severity can range from mild to very severe POD occurs in connection with a surgical procedure within the first four days after an intervention. 10-70% of all surgical patients above the age of 65 years are affected.
Delirium is not only a burden to the patient and their family by increasing functional and cognitive damages, and increasing mortality, it has a high impact on the economy, as well. A patient with delirium has a longer length of hospital stay, more complications, and often requires long-term care after being discharged from the hospital. All these aspects show the need for prevention of delirium.
There are various preoperative risk factors that influence the development of POD. Advanced age, preexisting cognitive impairment, depression and other psychopathologic symptoms, intake of psychotropic substances, sensory impairment like decrease in visual or auditory perception, impairment in daily life activities, dehydration, malnutrition, metabolic dysfunctions, urinary catheters, severe diseases and different comorbidities such as chronic cardiac insufficiency, atrial fibrillation, or previous history of stroke or infections favor the development of delirium.
The incidence of POD after major noncardiac surgery and the burden to patients and healthcare systems in general is high.
This research project is an observational cohort study by retrospective chart review of patients that underwent major noncardiac surgery at University Hospital Basel, Switzerland, in the years 2011-2015. The PODMAS study aims to identify risk factors for POD in a general surgical population.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients who underwent major noncardiac surgery at the University Hospital Basel during the years 2011-2015.
Key inclusion criteria (1 listed)
- All patients who underwent major noncardiac surgery at the University Hospital Basel during the years 2011-2015.
Key exclusion criteria (1 listed)
- Patients that died during the operation or one day after surgery.
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 |
|---|---|---|
| Major noncardiac surgeryVascular, thoracic, visceral, orthopedic, gynecologic, urologic, ENT, maxillo-facial, plastic and reconstructive surgery | Procedure or surgery | – |
Primary outcome
Incidence of postoperative delirium
Time frame: Daily assessment of postoperative delirium from postoperative day 1 up to postoperative day 30 or hospital discharge, whichever comes first
Incidence of postoperative delirium assessed by a validated delirium measurement tool (CAM, 3D-CAM, CAM-ICU, ICDSC, MDAS, GAR, DOSS, Nu-DESC, DRS-R-98, and/or patient chart review)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2020.
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The Danish Out-of-Hospital Cardiac Arrest Study
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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. This study is not recruiting at the moment.
Nicolai Goettel, MD principal investigator
University Hospital, Basel, Switzerland
Questions about this trial
What is this clinical trial studying?
An observational study of Postoperative Delirium, run by University Hospital, Basel, Switzerland.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 7 Jul 2020. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of postoperative delirium (time frame: Daily assessment of postoperative delirium from postoperative day 1 up to postoperative day 30 or hospital discharge, whichever comes first). 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 7 Jul 2020.