Implementation and Evaluation of the Selection Scheme of Peripheral Venous Infusion Devices for Hospitalized Children

Fudan University

Status: Completed

Conditions: Vascular Access Devices; Children,Hospitalized

Treatments: Other: the selection scheme of peripheral venous access devices; Other: the existing nursing routine

Study type: Interventional

Funder types: Other

Identifiers

NCT05378568

FNF202112

Details and patient eligibility

About

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.

Full 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.

Enrollment: 4,652 patients

Sex: All

Ages: 28 days to 18 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria for nurses:

• Nurses have been working in the siting more than 1 year
• Nurses who can independently perform nursing operations (complete the contents related to intravenous infusion in the standardized training of hospital and pass the examination)

Inclusion Criteria for patients:

• Patients receiving intravenous infusion
• Hospitalized patients aged 28 days to 18 years

Exclusion Criteria for nurses:

• Nurses who has not obtained the practicing qualification certificate
• Nurses refused to participate in the study

Exclusion Criteria for patients:

• The indwelling time is less than 24h
• Patients who were put into intravenous catheter at admission and did not receive new catheter during hospitalization
• Patients with only one stat(st) order for intravenous infusion during hospitalization
• Patients refused to participate in the study

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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4,652 participants in 2 patient groups

the selection scheme of peripheral venous access devices

Experimental group

Description:

To implement the selection scheme of peripheral venous access devices, based on the Clinical Practice Guideline on Infusion Therapy in Children. Then observe the appropriateness of peripheral venous access devices selection.

Treatment:

Other: the selection scheme of peripheral venous access devices

the existing nursing routine

Active Comparator group

Description:

Follow the existing nursing routine of intravenous infusion and the selection of peripheral venous access devices.

Treatment:

Other: the existing nursing routine