NCT04460716

Brief 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2011

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2011

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2015

Completed
4.5 years until next milestone

First Submitted

Initial submission to the registry

June 25, 2020

Completed
12 days until next milestone

First Posted

Study publicly available on registry

July 7, 2020

Completed
Last Updated

July 7, 2020

Status Verified

July 1, 2020

Enrollment Period

5 years

First QC Date

June 25, 2020

Last Update Submit

July 2, 2020

Conditions

Postoperative Delirium

Outcome Measures

Primary Outcomes (1)

  • 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

Interventions

Major noncardiac surgeryPROCEDURE

Vascular, thoracic, visceral, orthopedic, gynecologic, urologic, ENT, maxillo-facial, plastic and reconstructive surgery

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Emergence Delirium

Condition Hierarchy (Ancestors)

DeliriumConfusionNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsSigns and SymptomsNeurocognitive DisordersMental Disorders

Study Officials

  • Nicolai Goettel, MD

    University Hospital, Basel, Switzerland

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 25, 2020

First Posted

July 7, 2020

Study Start

January 1, 2011

Primary Completion

December 31, 2015

Study Completion

December 31, 2015

Last Updated

July 7, 2020

Record last verified: 2020-07