Predictors for Postoperative Delirium After Major Noncardiac Surgery in Adults (PODMAS)

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 Overview

• Status: Completed
• Conditions: Postoperative Delirium
• Intervention / Treatment: Procedure: Major noncardiac surgery

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 Type: Observational
• Enrollment (Actual): 5000

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

All patients who underwent major noncardiac surgery at the University Hospital Basel during the years 2011-2015.

Description

Inclusion Criteria:

• All patients who underwent major noncardiac surgery at the University Hospital Basel during the years 2011-2015.

Exclusion Criteria:

• Patients that died during the operation or one day after surgery.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	Daily assessment of postoperative delirium from postoperative day 1 up to postoperative day 30 or hospital discharge, whichever comes first

Collaborators and Investigators

• Sponsor: University Hospital, Basel, Switzerland
• Investigators: Principal Investigator: Nicolai Goettel, MD, University Hospital, Basel, Switzerland

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2011
• Primary Completion (Actual): December 31, 2015
• Study Completion (Actual): December 31, 2015

Study Registration Dates

• First Submitted: June 25, 2020
• First Submitted That Met QC Criteria: July 2, 2020
• First Posted (Actual): July 7, 2020

Study Record Updates

• Last Update Posted (Actual): July 7, 2020
• Last Update Submitted That Met QC Criteria: July 2, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Neurologic Manifestations; Confusion; Neurobehavioral Manifestations; Neurocognitive Disorders; Delirium
• Other Study ID Numbers: PODMAS

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No