NCT06226480

Brief Summary

Postoperative delirium (POD) is a common and severe complication in patients undergoing major surgery, especially in the elderly. POD has been proven to be associated with increased morbidity and mortality, institutionalization, and high healthcare costs. This retrospective cohort study aimed to use machine learning methods to develop clinically meaningful models to support clinical decision making.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
3,967

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 18, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 26, 2024

Completed
1 month until next milestone

Study Start

First participant enrolled

February 25, 2024

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 20, 2024

Completed
11 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2024

Completed
Last Updated

December 3, 2024

Status Verified

January 1, 2024

Enrollment Period

5 months

First QC Date

January 18, 2024

Last Update Submit

December 2, 2024

Conditions

Keywords

postoperative delirium

Outcome Measures

Primary Outcomes (1)

  • Number of participants with postoperative delirium

    The following descriptive words and the derivatives were searched from the medical records: "delirium", "agitation", "hallucinations", "combative behavior", "inattention", "confusion", "mental status change", "disorientation", "drowsy". Medical records with the presence of these keywords were reviewed by an independent researcher, and medical records presented the aforementioned symptoms preoperatively were excluded. Postoperative delirium was diagnosed according to the Diagnostic and Statistical Manual of Mental Disorders, fourth edition (DSM-IV) criteria.

    The first three postoperative days

Eligibility Criteria

Age65 Years+
Sexall
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Elderly patients undergoing thoracic surgeries.

You may qualify if:

  • aged ≥ 65 years
  • elective segmentectomy, lobectomy, or esophagectomy surgeries
  • general anesthesia

You may not qualify if:

  • surgery length less than 1 hour
  • preoperative cognitive dysfunction
  • admission to the intensive care unit
  • second operation within 24 hours
  • missing data for any variables

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Affiliated Hospital of Nantong University

Nantong, Jiangsu, 226001, China

Location

MeSH Terms

Conditions

Emergence Delirium

Condition Hierarchy (Ancestors)

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

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 18, 2024

First Posted

January 26, 2024

Study Start

February 25, 2024

Primary Completion

July 20, 2024

Study Completion

July 31, 2024

Last Updated

December 3, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will not share

Only IPD used in the results publication will be shared upon reasonable request

Locations