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临床试验/NCT04085042
NCT04085042已完成不适用

Impact of a Multimodal Intervention on Peripheral Venous Catheterization of Cancer Patients

Escola Superior de Enfermagem de Coimbra1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2021年5月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
200
试验地点
1
主要终点
PIVC-related complications

研究概览

简要总结

Peripheral intravenous catheterization (PIVC) is the most frequent invasive clinical procedure in a hospital setting, associated with significant complication rates for the patient, compromising their well-being, as well as the quality, safety, and efficacy of the care provided. The traditional approach to PIVC is considered reactive and ineffective, resulting in the exhaustion of the patients' peripheral venous access prior to consideration of other access methods and options (Moureau et al., 2012).

Evidence suggests that the safety and effectiveness of patients with a peripheral catheter are also intrinsically associated with the adequacy of materials and technologies used in clinical contexts for vein selection, as well as for catheter insertion and maintenance care (Marsh, Webster, Mihala & Rickard, 2017). Several studies point to the inadequacy of the technologies and medical devices used in this area, enhancing the occurrence of complications such as infection, phlebitis, occlusion and accidental catheter removal (Braga, 2017; Costa, 2017; Nobre & Martins, 2018).

The project investigators aim to determine whether the use of a PIVC pack will significantly reduce associated complications when compared with the usual care. Additionally, the research team aims to determine if the use of a PIVC pack will reduce the number of insertion attempts and overall procedure time, as well as improving patient and provider satisfaction.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Double (Participant, Outcomes Assessor)

入排标准

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

入选标准

  • Participants who require peripheral intravenous catheterization as part of their therapeutic plan (caliber 20G or 22G);
  • Participants whose primary nurse agrees to participate in the study;
  • Participants who are able to give written assent or oral assent.

排除标准

  • Confused and/or disoriented participants;
  • Participants who are unable to communicate orally and/or in writing.

结局指标

主要结局

PIVC-related complications

时间窗: This outcome will be assessed immediately following intervention, an average of 5 minutes. This outcome will be assessed through study completion, an average of 6 months

Evaluated through a self-report scale where the nurse identifies a set of indicators associated to the occurrence of immediate complications during the procedure (extravasation, puncture of proximal anatomical structures, hematoma, etc.)

次要结局

  • Number of attempts to successful intravenous catheter placement(Immediately following intervention, an average of 5 minutes. This outcome will be assessed through study completion, an average of 6 months.)
  • Nurse satisfaction(This outcome will be assessed immediately following intervention, an average of 20 minutes. This outcome will be assessed through study completion, an average of 6 months)
  • Successful intravenous catheterization on the first attempt(This outcome will be assessed immediately following intervention, an average of 5 minutes. This outcome will be assessed through study completion, an average of 6 months)
  • Patient satisfaction(This outcome will be assessed immediately following intervention, an average of 20 minutes. This outcome will be assessed through study completion, an average of 6 months)
  • Time to successful placement (in minutes)(From time of randomization until the time of successful intravenous catheter placement, assessed through study completion, an average of 6 months.)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Paulo Costa

MSc, RN

Escola Superior de Enfermagem de Coimbra

研究点 (1)

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