Ignite Creation Date:
2025-12-24 @ 5:58 PM
Ignite Modification Date:
2025-12-26 @ 7:26 AM
Study NCT ID:
NCT05378568
Status:
COMPLETED
Last Update Posted:
2023-02-22
First Post:
2022-02-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Implementation and Evaluation of the Selection Scheme of Peripheral Venous Infusion Devices for Hospitalized Children
Sponsor:
Children's Hospital of Fudan University
Organization:
Study Overview
Official Title:
Implementation and Evaluation of the Selection Scheme of Peripheral Venous Infusion Devices for Hospitalized Children: a Stepped Wedge Cluster Randomized Trial
Status:
COMPLETED
Status Verified Date:
2023-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study is a stepped wedge cluster randomized trial design. The object is to evaluate the influence on patient outcomes, medical staff's evidence-based practice behavior and hospital context after implementation of the selection scheme of venous access devices comes from" Evidence-based guidelines for clinical practice of intravenous infusion therapy in children". This study sought to compare the appropriateness of peripheral venous access device selection, to compare the incidence of infiltration and extravasation and the cost of venous infusion consumables before and after the implementation of the scheme.
Detailed Description:
This study aimed to improve the standardization and suitability of device use and reduce complications associated with intravenous fluids by implementing best practice evidence for intravenous fluid device selection in children. In 2021, the Chinese Journal of Evidence-Based Pediatrics released the " Evidence-based guidelines for clinical practice of intravenous infusion therapy in children". The researchers used the evidence in this guideline as a standard to understand the current status of clinical intravenous infusion device selection and the gap between the current situation and the evidence. The evidence tailor, baseline review, develop implementation plan, conduct implementation research. A stepped wedge cluster randomized trial divided into 5 steps, 10 clusters(units), and the step size was one month. Each included ward of a tertiary first-class pediatric hospital was regarded as a group, and each step was included into randomized two groups, and the observation was maintained for one month until all units were included in the intervention in the fifth month, with a total of 6 research periods. Given the practicality of the study design, limited additional inclusion and exclusion criteria will be added.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: