With the Development of Research, New Algorithms and Tech... | NCT07121309

Studies
With the Development of Research, New Algorithms and Technologies Have Emerged, One of Which is Machine Learning. Machine Learning Can Extract Key Factors From Vast Amounts of Data, Identify Underlying Patterns, and Predict Future Trends. In Recent Years, Machine Learning Has Been Widely Used in

NCT07121309

Sponsor

Second Affiliated Hospital of Soochow University

Status

Completed

Last Update Posted

Aug 13, 2025Actual

Enrollment

901Actual

Phase

Not provided

Conditions

Delirium

Interventions

Not provided

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

ID	Type	Description	Link
JD-HG-2025-022	Other Identifier	SecondSoochowU

Brief Title

With the Development of Research, New Algorithms and Technologies Have Emerged, One of Which is Machine Learning. Machine Learning Can Extract Key Factors From Vast Amounts of Data, Identify Underlying Patterns, and Predict Future Trends. In Recent Years, Machine Learning Has Been Widely Used in

Status Module

Record Verification Date

Aug 2025

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 17, 2024Actual

Primary Completion Date

Mar 3, 2025Actual

Completion Date

Mar 3, 2025Actual

First Submitted Date

Aug 6, 2025

First Submission Date that Met QC Criteria

Aug 6, 2025

First Posted Date

Aug 13, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 6, 2025

Last Update Posted Date

Aug 13, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The aim of this study is to construct a predictive model for postoperative delirium in elderly patients with hip fractures. The main question it answers is to construct a risk prediction model for hip fractures in the elderly through six machine learning methods, compare which method's model is better, and conduct external validation of the model's stability to provide a reference for the early clinical detection of postoperative delirium in elderly hip fracture patients.

The clinical data of elderly patients with hip fractures have been collected in clinical practice and the model has been constructed.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

901Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Postoperative delirium	The Memory and Delirium Assessment Scale (MDAS) was used for delirium risk screening and assessment, including consciousness, attention, speech, behavior, and sleep aspects.	The day after the operation

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age ≥ 60 years; diagnosed with hip fracture by X-ray; patients who underwent surgical treatment.

Exclusion Criteria:

Patients with other severe diseases (Patients who reach grade IV or higher according to the American Society of Anesthesiologists (ASA) health status classification;Suffer from end-stage diseases;there is multiple organ dysfunction syndrome (MODS) or single organ failure); patients with mental disorders; patients participating in other studies.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

60 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients over 60 years old who undergo surgical treatment for hip fractures

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
SecondSoochowU		Suzhou	Jiangsu	215004	China

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Derived Section

Miscellaneous Info Module

Version Holder

Jul 10, 2026

Removed Countries

Not provided

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

MeSH Terms

Intervention Browse Module

No data available

No data is available for this block.

ID	Term
D003693	Delirium
D006620	Hip Fractures

Ancestor Terms

ID	Term
D003221	Confusion
D019954	Neurobehavioral Manifestations
D009461	Neurologic Manifestations
D009422	Nervous System Diseases
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms
D019965	Neurocognitive Disorders
D001523	Mental Disorders
D005264	Femoral Fractures
D050723	Fractures, Bone
D014947	Wounds and Injuries
D025981	Hip Injuries
D007869	Leg Injuries