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Implementation of an Infusion Management Scheme to Improve Patient Outcome in Tertiary Children's Hospitals

Fudan University logo

Fudan University

Status

Terminated

Conditions

Infusion
Children,Hospitalized
Infections

Treatments

Other: Infusion management scheme

Study type

Interventional

Funder types

Other

Identifiers

NCT05152446
FNDGJ202110

Details and patient eligibility

About

This study is a multi-center before-after trial design. The object is to observe whether the incidence of central line associated blood stream infection(CLABSI) will tend to descend compared with retrospective electronic medical record data after implementation of an infusion management scheme which comes form " Clinical Practice Guideline on Infusion Therapy in Children " .

Full description

Infusion therapy is an important part in pediatric ward. Most hospitalized children need indwelling vascular access devices to receive infusion therapy. Much attention has been paid to possible serious or fatal complications due to immature immune system, poor communication ability and cognitive disorder in children during catheter placement, use and maintenance. Reducing the complications related to central venous catheter has become the focus of the global health care system. Studies have shown that the technical level of operators is in connection with the incidence of CLABSI, and an intravenous infusion team (IV Team) is the key to preventing CLABSI, which may fundamentally improve the clinical outcomes of pediatric patients. From December 2021 to April 2023, taking Children's Hospital of Fudan University as the leading center, Xiamen Children's Hospital, Anhui Provincial Children's Hospital, Dalian Municipal Women and Children's Medical Group, Tongji Hospital, First Affiliated Hospital of Guangxi Medical University, Qidong Women's and Children's Health, Chengdu Women's and Children's Central Hospital, Hunan Children's Hospital as the cooperation centers. A retrospective review of electronic medical record data will be collected first. The intervention is composed of setting up a pediatric intravenous infusion team; carrying out a quality improvement in collecting and sending suspected CLABSI samples; providing infusion training curriculums to nurses in forms of lectures, group discussions, operation demonstrations, and scenario simulations, holding practice review meeting with them; providing elements to caregivers of educational leaflet, nurse-provided education during patients' infusion therapy.

Enrollment

1,000 patients

Sex

All

Ages

1 day to 18 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria for centers:

  • A tertiary children's hospital with more than 300 beds
  • The vice president in charge of nursing affairs, the director of nursing department and the director of hospital infection control department all agree in participating in this study with written permission, which include total acceptance of infusion management scheme and outcome indicators report as required
  • To obtain the approval from Ethics Committee of the hospital

Inclusion Criteria for patients:

  • Hospitalized children aged 0~18 years
  • Catheterization and maintenance in the same center
  • The indwelling time is longer than 48h

Exclusion Criteria:

  • The vice president in charge of nursing affairs or the director of nursing department inform the researcher to withdraw from this study with written form and should clear reasons
  • The number of cases for suspected CLABSI sample actually submitted for inspection / The number of cases for suspected CLABSI sample should submitted for inspection<0.9
  • The awareness rate of infusion management scheme in clinical nurses is less than 90% and the qualification rate of the practice examination in clinical nurses is less than90% during inspection

Trial design

Primary purpose

Prevention

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

1,000 participants in 1 patient group

Infusion management scheme
Experimental group
Description:
To implement infusion management scheme, then observe the continuous changes.
Treatment:
Other: Infusion management scheme

Trial contacts and locations

9

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Central trial contact

Yingwen Wang; Ying Gu

Data sourced from clinicaltrials.gov

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