Construction and Validation of Risk Prediction Model for... | NCT04924959

Studies
Construction and Validation of Risk Prediction Model for PICC Catheter Displacement

NCT04924959

Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Status

Unknown status

Last Update Posted

Jun 14, 2021Actual

Enrollment

663Actual

Phase

Not provided

Conditions

Cancer Patients With PICC

Interventions

Logistic Regression Analysis

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

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2021

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 27, 2019Actual

Primary Completion Date

Jun 30, 2022Estimated

Completion Date

Oct 30, 2022Estimated

First Submitted Date

Jun 10, 2021

First Submission Date that Met QC Criteria

Jun 10, 2021

First Posted Date

Jun 14, 2021Actual

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

Jun 10, 2021

Last Update Posted Date

Jun 14, 2021Actual

Name	Class
Sir Run Run Shaw Hospital	OTHER
Zhejiang Provincial People's Hospital	OTHER

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 occurrence of PICC catheter displacement is caused by many factors. In order to predict the risk of PICC and early warn high-risk patients, this study prospectively included patients with PICC catheter in a three Grade-A hospitals in June 2019, analyzed a variety of related factors, built a scientific and effective risk prediction model of PICC catheter displacement, and verified the goodness of fit and differential validity of the model.

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

663Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Modeling Group			Other: Logistic Regression Analysis
Validation Group

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Logistic Regression Analysis	Other	Using logistic regression analysis to analyze the independent risk factors of PICC catheter displacement	Modeling Group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Prediction Model of PICC catheter displacement	A mathematical model for predicting PICC catheter displacement	3 years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients with PICC

Exclusion Criteria:

Patients with primary ectopia during PICC catheterization
Patients with secondary ectopic adjusting length of catheter exposure
Patients with mental illness and cognitive impairment
Patients with incomplete clinical data

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Cancer patients with PICC

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
2nd Affilicated Hospital, School of Medicine, Zhejiang University		Hangzhou	Zhejiang	310000	China