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临床试验/NCT07649499
NCT07649499已完成不适用

The Effect of Care Bundle in Preventing the Frequency of Peripheral Intravenous Catheter-Related Infiltration and Phlebitis in the Pediatric Emergency Department: A Quasi-Experimental Study

Istanbul University - Cerrahpasa1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2024年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
200
试验地点
1
主要终点
Incidence of Peripheral Intravenous Catheter-Related Infiltration

研究概览

简要总结

This quasi-experimental study evaluates the effectiveness of a care bundle in preventing peripheral intravenous catheter (PIVC)-related infiltration and phlebitis in pediatric emergency department patients. The care bundle includes interventions such as nurse education, hand hygiene, aseptic techniques, and the use of antiseptic solutions (2% chlorhexidine and 70% alcohol) for PIVC insertion and maintenance. The study compares the incidence of infiltration and phlebitis between the intervention and control groups.

详细描述

This study was conducted in the Pediatric Emergency Department of Dr. Sadi Konuk Education and Research Hospital, involving 200 pediatric patients, with 100 in the intervention group and 100 in the control group. The intervention group received a care bundle, which included education on peripheral intravenous catheter management, hand hygiene, aseptic techniques, and the use of antiseptic solutions (2% chlorhexidine and 70% alcohol). The control group received standard care according to routine practice. The incidence of infiltration and phlebitis was compared between the groups, with data collected using the Visual Infusion Phlebitis Assessment Scale (VIPAS) and Pediatric Peripheral Intravenous Infiltration Scale (PPIIS).

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
28 Days 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Children admitted to the Pediatric Emergency Department
  • First-time peripheral intravenous catheter (PIVC) insertion Ages between 28 days to 18 years
  • At least 6 hours of observation after catheter insertion
  • Fluid administration in the observation area (e.g., 5% dextrose + 0.45% NaCl + 5/10 cc potassium)
  • Written informed consent obtained from parents/legal guardians
  • Children willing to participate in the study

排除标准

  • Children with skin problems (e.g., epidermolysis bullosa)
  • Children allergic to products used in the care bundle
  • Children who have undergone procedures that could cause catheter displacement or infiltration (e.g., lumbar puncture) Children with chronic vascular issues (e.g., vasculitis, hematologic disorders, congenital vascular anomalies)
  • Children transferred to intensive care or another department after PIVC insertion
  • Children with clinical conditions that prevent standard care bundle application (e.g., extreme agitation, inability to immobilize extremities)

研究组 & 干预措施

Intervention Group (Care Bundle)

Experimental

The intervention group will receive a care bundle consisting of the following:

Nurse Education on peripheral intravenous catheter (PIVC) management.

Hand Hygiene and adherence to aseptic techniques during PIVC insertion.

Use of 2% chlorhexidine and 70% alcohol antiseptic solutions for PIVC insertion.

Hydrocolloid transparent adhesive bandage for stabilization of the catheter.

Nurses will avoid performing more than two attempts for PIVC insertion.

Aseptic technique will be strictly followed during PIVC insertion and maintenance.

干预措施: Care Bundle for PIVC Management (Behavioral)

Control Group (Standard Care)

No Intervention

The control group will receive standard care as per routine practice in the pediatric emergency department:

Standard peripheral intravenous catheter (PIVC) insertion procedures as performed by clinical staff.

No additional interventions such as nurse education or the specific antiseptic solutions or stabilization methods will be applied.

结局指标

主要结局

Incidence of Peripheral Intravenous Catheter-Related Infiltration

时间窗: From the time of catheter insertion to 6 hours post-insertion

The primary outcome is the incidence of PIVC-related infiltration in pediatric patients. Infiltration will be assessed using the Pediatric Peripheral Intravenous Infiltration Scale (PPIIS).

Incidence of Peripheral Intravenous Catheter-Related Phlebitis

时间窗: From the time of catheter insertion to 6 hours post-insertion.

the incidence of PIVC-related phlebitis. Phlebitis will be assessed using the Visual Infusion Phlebitis Assessment Scale (VIPAS).

次要结局

  • First Attempt Success Rate for PIVC Insertion(Procedure (During initial PIVC insertion attempt.))
  • Number of PIVC Insertions(At the time of PIVC insertion procedure)
  • Nurse Adherence to Care Bundle Protocol(At the time of PIVC insertion procedure)

研究者

发起方
Istanbul University - Cerrahpasa
申办方类型
Other
责任方
Principal Investigator
主要研究者

Gizem Çolak

Principal Investigator

Istanbul University - Cerrahpasa

研究点 (1)

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