跳至主要内容
临床试验/NCT07450729
NCT07450729招募中不适用

Randomized, Open-label, Parallel-arm, Controlled Study to Evaluate the Stabilization of Peripheral Venous Catheters Through the Application of Cyanoacrylate Skin Adhesive to the Exit Site in Pediatric Patients With Emergency Room Access.

Meyer Children's Hospital IRCCS1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2025年1月14日最近更新:
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
300
试验地点
1
主要终点
Number of dislocations of the vascular access device (VADs)

研究概览

简要总结

A venous access device (VADs) is a biocompatible plastic catheter that establishes a connection between the skin surface and a venous system. They can be categorized using various classifications; notably, based on the position of the catheter tip, they are distinguished into central venous catheters (CVCs) and peripheral venous catheters (PVCs). Depending on their length, PVCs can be further divided into long-cannula PVCs and short-cannula PVCs.

Currently, these catheters are stabilized "in situ" using transparent semipermeable dressings with a high moisture vapor transmission rate (MVTR), which keep the insertion site visible. Considering the pediatric patient population, this type of stabilization is currently somewhat archaic, and accidental displacement of PVCs is frequently encountered, along with subsequent complications such as extravasation, occlusion, phlebitis, and local infections.

The addition of skin glue to the transparent semipermeable dressing ensures optimal stabilization of the device, reducing dislodgement, further complications, and consequently the need for multiple punctures for repositioning.

Due to various clinical conditions, some patients presenting to the Emergency Department have a venous network that is difficult to identify by direct visualization or palpation. In these patients, the occurrence of an accidental displacement would significantly compromise the quality of care. Currently, there are no studies in the literature conducted in a pediatric emergency department that demonstrate the superiority of using cyanoacrylate glue for PVC stabilization compared to the semipermeable dressing alone. This study aim to investigate the use of cyanoacrylate glue for stabilizing venous access devices in the emergency setting as well, and to evaluate potential improvements to current daily clinical practice.

The primary objective is to evaluate whether applying cyanoacrylate skin glue at the exit site provides better stabilization of a correctly placed peripheral venous catheter (PVC) compared to PVC stabilization with a transparent semipermeable dressing alone.

研究设计

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

入排标准

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

入选标准

  • Age 0-18 years old
  • Venous access device for at least 24 hours.
  • Informed consent form signed

排除标准

  • Patients with language barriers
  • patients with pre-existing central venous access
  • patients requiring immediate surgery with venous access placed under sedation
  • skin lesions in the affected area
  • patients exhibiting psychomotor agitation
  • patients assigned to the emergency code
  • unaccompanied minors

研究组 & 干预措施

Experimental group

Experimental

干预措施: cyanoacrylate glue (Procedure)

Standard of care

No Intervention

结局指标

主要结局

Number of dislocations of the vascular access device (VADs)

时间窗: 6 hours post- VADs insertion

次要结局

  • Number of dislocations of the vascular access device (VADs)(12, 24, 36, 48, and 72 hours post- VADs insertion)
  • Change in Visual Exit Site (VES) score(6, 12, 24, 36, 48, and 72 hours post- VADs insertion)
  • Correlation between the percentage of displacement of venous access device and DIVA score.(6, 12, 24, 36, 48, and 72 hours post- VADs insertion)

研究者

发起方
Meyer Children's Hospital IRCCS
申办方类型
Other
责任方
Principal Investigator
主要研究者

Giulia Caccia

MD

Meyer Children's Hospital IRCCS

研究点 (1)

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