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临床试验/NCT07013994
NCT07013994已完成不适用

Comparison of Traditional and Ultrasound-Guided Techniques for Vascular Access in Patients With Difficult Venous Access in Emergency Department: Randomized Clinical Trial Protocol

Mercedes Segunda Peralta Gámez1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2025年8月15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
Scores obtained by DIVA patients on the A-DICAVE scale

研究概览

简要总结

The aim of this clinical trial is to compare the use of ultrasound versus the traditional palpation and visualization technique for vascular punctures, both peripheral venous and arterial punctures for arterial blood gas sampling, in patients presenting to hospital emergency departments. The main questions it seeks to answer are:

Does the use of ultrasound facilitate peripheral venous cannulation in patients with difficult venous access in the emergency department? Does the use of ultrasound facilitate arterial puncture in patients presenting to the emergency department who require arterial blood gases?

The researchers will compare the use of ultrasound with the traditional technique in vascular punctures by emergency department nurses. To determine the differences in the number of attempts needed, the number of professionals needed to perform the technique, the time invested, the pain produced with both techniques, etc., the researchers will compare the use of ultrasound with the traditional technique for vascular punctures by emergency department nurses.

详细描述

Introduction It is estimated that 90% of patients attending Emergency Departments (ED) require venipuncture, with short peripheral intravenous catheters (PIVC) being the most used invasive devices in healthcare settings. However, there are patients for whom even experienced nurses require more than two attempts to successfully perform the procedure; these patients are classified as having difficult venous access (DIVA). This condition is estimated to occur in 10-24% of adult patients and up to 37% of children. Arterial punctures, often performed to collect blood samples or arterial blood gases (ABG), are similarly common in ED, with first-attempt failure rates reported at approximately 10%.

Failed punctures result in deterioration of the patient's vein and arterial capital, as well as causing pain, stress, and delays in medical care. They also create highly demanding situations for nursing professionals and lead to increased use of human and material resources. To mitigate these issues, certain predisposing factors for DIVA patients have been identified, including obesity, oedema, previous cannulations, and hypotension. Additionally, support tools such as the DIVA scale for pediatric patients and the A-DICAVE scale, validated in 2020 by Dr Salleras, have been developed. The latter is specifically designed for adult patients attending ED. However, no validated scales currently exist for identifying patients at risk of difficult ABG sampling.

Once patients with DIVA are identified, or when difficulties in performing ABG are anticipated, healthcare professionals can employ ultrasound-guided techniques to facilitate these procedures. Ultrasound allows for easier identification of vascular access points, as well as real-time confirmation of puncture success and correct SPVC placement.

Although an increasing number of authors advocate for the use of ultrasound in PIVC placement, existing literature primarily focuses on surgical, anesthetic, or pediatric patients. Consequently, ultrasound-guided techniques are not yet widely adopted, and patients continue to experience the consequences of multiple failed attempts. In the context of ED, studies such as those by Dr Salleras and Rodríguez-Herrera highlight the feasibility and benefits of these techniques. Nevertheless, ultrasound-guided vascular access has not yet been systematically implemented through standardized protocols.

This present study aims to provide evidence on the utility of validated scales for identifying DIVA patients, as well as the benefits of ultrasound-guided vascular punctures in ED. It will consider not only procedural success rates but also the satisfaction of healthcare professionals, patients, and their families.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
Single (Outcomes Assessor)

入排标准

性别
All
接受健康志愿者
否

入选标准

  • •Prescription for CIP or GA cannulation.
  • •Informed consent signed by the patient or patient's representative.
  • •A score ≥3 on the A-DICAVE scale or ≥4 on the DIVA scale for PIVC.

排除标准

  • •Scores below 3 on the A-DICAVE scale or below 4 on the DIVA scale for PIVC.
  • •Inability to obtain informed consent from the patient or patient's representative

研究组 & 干预措施

Echoguided technique

Experimental

Ultrasound will be used for peripheral venous cannulation and arterial puncture by direct visualisation of the needle in the selected structure.

干预措施: peripheral venous cannulation with ultrasound-guided technique (Procedure)

Echoguided technique

Experimental

Ultrasound will be used for peripheral venous cannulation and arterial puncture by direct visualisation of the needle in the selected structure.

干预措施: Arterial gas puncture using ultrasound-guided technique (Procedure)

Traditional technique

Active Comparator

Vascular puncture will be performed using the traditional visualisation/palpation technique.

干预措施: Peripheral venous cannulation with traditional technique (Procedure)

Traditional technique

Active Comparator

Vascular puncture will be performed using the traditional visualisation/palpation technique.

干预措施: Arterial puncture by traditional technique (Procedure)

结局指标

主要结局

Scores obtained by DIVA patients on the A-DICAVE scale

时间窗: At the beginning

Results of the assessment by the adult patients included in the study using the A-DICAVE scale (Adult Venous Catheterisation Difficulty Scale). With values from 0 to 5. Values greater than or equal to 3 indicate that the patient has difficult venous access.

Scores obtained by DIVA patients on the DIVA scale

时间窗: At the beginning

Assessment of paediatric patients using the DIVA scale (Dificil Acceso Vascular). Values above 4 indicate that the patient has a difficult venous access.

Number of patients undergoing successful peripheral venous cannulation

时间窗: During the intervention, expected time 1 year.

Successful peripheral venous cannulation using both techniques

Time spent on the techniques to be compared

时间窗: During the intervention, expected time 1 year.

Time spent on the techniques from start to completion of the procedure

Number of professionals involved in the technique

时间窗: During the intervention, expected time 1 year.

Number of nursing professionals required to perform the technique successfully.

次要结局

  • Pain produced by the techniques(During the intervention, expected time 1 year.)
  • Satisfaction perceived by professionals after performing the techniques(During the intervention, expected time 1 year.)

研究者

发起方
Mercedes Segunda Peralta Gámez
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Mercedes Segunda Peralta Gámez

Graduate in nursing, master's degree in research in nursing sciences.

Nuestra Señora de Sonsoles Hospital in Ávila

研究点 (1)

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