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临床试验/NCT07411430
NCT07411430尚未招募不适用

Peripheral Venous Access Management by Radiologic Technologists in Radiodiagnostic Procedures: Training, Organization, and Patient Safety. Evaluation of a Structured Training Program and Its Clinical and Organizational Effects

Fondazione Policlinico Universitario Agostino Gemelli IRCCS0 个研究点目标入组 9 人开始时间: 2026年2月15日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
9
主要终点
Effectiveness of the Structured Theoretical-Practical Training Program on Peripheral Venous Access Placement

研究概览

简要总结

The goal of this interventional study is to evaluate the impact of a structured training program on the ability of Radiologic Technologists (RTs) to safely and effectively perform peripheral venous access (PVA) placement for contrast media administration in a radiodiagnostic setting.

The study focuses on adult patients undergoing contrast-enhanced imaging procedures and on Radiologic Technologists who have completed a competency-based theoretical and practical training program on peripheral venous access management.

The main questions it aims to answer are:

  • Does a structured training program improve the theoretical knowledge and technical competencies of Radiologic Technologists in peripheral venous access placement?
  • What is the incidence of complications associated with peripheral venous access placement performed by trained Radiologic Technologists in routine clinical practice?
  • How do patients perceive the procedure in terms of pain, safety, procedural success, and overall satisfaction?

Participants:

  • Radiologic Technologists will participate in a structured theoretical and practical training program focused on peripheral venous access placement for contrast media administration.
  • Radiologic Technologists will perform peripheral venous access placement during routine radiodiagnostic procedures following completion of the training.
  • Patients undergoing contrast-enhanced imaging will receive peripheral venous access placement performed by trained Radiologic Technologists and will complete questionnaires assessing pain, satisfaction, and perceived safety of the procedure.

详细描述

This prospective, single-center, single-arm interventional study aims to evaluate the quality and impact of a structured theoretical and practical training program designed to qualify Radiologic Technologists (RTs) to perform peripheral venous access (PVA) placement for contrast media administration in a radiodiagnostic setting.The primary objective is to assess the effectiveness of the training program by evaluating the acquisition of technical competencies and theoretical knowledge among RTs. In addition, the study evaluates the clinical impact of the intervention in routine practice by analyzing the incidence of PVA-related complications and the patient experience in terms of pain perception, procedural success, and perceived safety.Secondary objectives include assessing RTs' perceptions of the training program with regard to organization, clarity of content, educational effectiveness, and perceived impact on professional practice. The study also aims to measure the incidence of adverse events associated with PVA placement performed by trained RTs and to examine patient-reported outcomes, including pain, first-attempt success rate, procedure duration, and overall satisfaction.

Study Design and Duration: This is an interventional, prospective, single-center, single-arm study that does not involve investigational drugs or medical devices. The intervention consists exclusively of a competency-based training program. The study will begin following Ethics Committee approval and administrative authorization and will have a total planned duration of six months.

The first month (Phase 1 - Intervention Implementation) will include delivery of the theoretical and practical training program and supervised clinical practice. Each RT will complete at least 20 supervised PVA placements. At the end of this phase, RTs will complete a structured survey assessing training effectiveness and perceived preparedness.The following four months (Phase 2 - Intervention Evaluation) will involve data collection during routine clinical activity, with RTs independently performing PVA placement and completing standardized data collection forms. The final month will be dedicated to data analysis and reporting.

Study Setting The study will be conducted at the Radiodiagnostic Service of the Columbus site of the Fondazione Policlinico Universitario A. Gemelli IRCCS in Rome. Study activities will primarily take place in the computed tomography (CT) unit, where contrast media administration routinely requires PVA placement. All procedures will be performed as part of routine clinical practice following completion of the training program, in accordance with institutional procedures and international guidelines for short peripheral venous catheter insertion.

Study Population The study population includes Radiologic Technologists working in the Radiodiagnostic Service and adult patients undergoing contrast-enhanced imaging examinations. Approximately 384 adult patients (≥18 years) undergoing CT or MRI examinations requiring contrast media administration will be included. RT inclusion criteria, include voluntary participation with informed consent and completion of the training program. RTs who do not provide informed consent will be excluded.Patient inclusion criteria include age ≥18 years, informed consent, and clinical indication for PVA placement. Exclusion criteria include age <18 years, severe cognitive impairment, lack of informed consent, and clinical conditions that make venipuncture complex or unsafe.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Health Services Research
盲法
None

入排标准

性别
All
接受健康志愿者

入选标准

  • for Radiologic Technologists (RTs):
  • Voluntary participation and provision of written informed consent.
  • Completion of the structured theoretical and practical training program for peripheral venous access placement for contrast media administration.
  • Inclusion Criteria for Patients:
  • Age ≥18 years
  • Provision of written informed consent.
  • Undergoing a contrast-enhanced CT or MRI examination requiring peripheral venous access placement for contrast media administration.

排除标准

  • for Radiologic Technologists (RTs):
  • - No written informed consent.
  • Exclusion Criteria for Patients:
  • Age <18 years.
  • Severe cognitive impairment that precludes valid informed consent or completion of the patient survey.
  • No written informed consent.
  • Clinical conditions that make peripheral venous access placement complex or unsafe, as determined by the clinical team.

结局指标

主要结局

Effectiveness of the Structured Theoretical-Practical Training Program on Peripheral Venous Access Placement

时间窗: one month

Effectiveness of the training program will be assessed through: 1. A structured post-training survey evaluating perceived knowledge acquisition, preparedness, autonomy, and overall training impact (categorical Likert-type responses), and 2. A structured practical competency assessment evaluating procedural performance. Survey responses will be reported as absolute frequencies (n) and percentages (%) for each response category. Practical competency will be reported as: 1. Proportion (%) of Radiologic Technologists achieving successful completion of supervised peripheral venous access procedures, and 2. Proportion (%) reaching predefined competency level after training.

次要结局

  • Incidence of Peripheral Venous Access-Related Complications(Up to 4 months)
  • First-Attempt Success Rate of Peripheral Venous Access Placement(Up to 4 months)
  • Patient-Reported Pain During and After Peripheral Venous Access Placement(Immediately after procedure (Up to 4 months))
  • Patient-Reported Procedural Experience and Satisfaction(Immediately after procedure (Up to 4 months))
  • Procedure Duration (Arrival to Examination Start)(Up to 4 months)

研究者

申办方类型
Other
责任方
Sponsor

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