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Идёт набор NCT07208175

Effectiveness of Ultrasound-Guided Versus Traditional IV Insertion by Oncology Nurses in Adult Population Recieving Systemic Anti-cancer Therapy

Без фазы С лечением Cancer

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Ultrasound-Guided Peripheral Intravenous Catheter Insertion, Traditional Peripheral Intravenous Catheter Insertion.
Кому может быть актуально
Состояния в реестре: Cancer. Базовые параметры: Без ограничений · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Ирландия
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

Effectiveness of Ultrasound-guided Peripheral Intravenous Catheter (EUPIC) Insertion Versus Traditional (Touch and Feel) Insertion Approaches by Oncology Nurses. A Mixed-methods Randomized Controlled Trial (RCT)

Обзор

What is this study about? This study is comparing two different methods nurses use to place an intravenous (IV) drip, which is needed for many cancer treatments. Traditional method: The nurse finds a vein by touch and sight. Ultrasound-guided method: The nurse uses a small, handheld ultrasound scanner to see the vein under the skin to help guide the needle. Why is it important? Sometimes it can take more than one attempt to get an IV drip in place, which can be uncomfortable. For cancer patients, whose veins can be more fragile, this is a common challenge. This research will help us find out if using ultrasound helps get the IV in successfully on the first try more often, which can make the treatment experience better. What does participation involve? If you choose to take part, you will be randomly assigned (like a coin toss) to have your IV placed with either the traditional method or the ultrasound method. The research team will then collect some information about the IV placement. Your participation is entirely voluntary and will not affect your standard medical care.

Подробное описание

Brief Summary:

This study compares two different methods nurses use to place an intravenous (IV) drip, which is needed for many cancer treatments.

Traditional method: The nurse finds a vein by touch and sight.

Ultrasound-guided method: The nurse uses a small, handheld ultrasound scanner to see the vein under the skin to help guide the needle.

Sometimes it can take more than one attempt to get an IV drip in place, which can be uncomfortable. For cancer patients, whose veins can be more fragile, this is a common challenge. This research will help determine if using ultrasound helps achieve successful IV placement on the first try more often, which may improve the treatment experience.

Participation involves random assignment (like a coin toss) to have the IV placed with either the traditional method or the ultrasound method. The research team will then collect some information about the IV placement. Participation is entirely voluntary and will not affect standard medical care.

Detailed Description:

Peripheral intravenous catheter (PIVC) insertion is a fundamental procedure for administering systemic anti-cancer therapy (SACT). A significant clinical problem in oncology is the high prevalence of patients with difficult intravenous access (DIVA), leading to multiple insertion attempts, procedural pain, anxiety, and treatment delays. The traditional landmark technique, reliant on visual and palpatory cues, is often insufficient for this population.

Ultrasound guidance represents a potential technological advancement for PIVC insertion, allowing for visualization of deeper vasculature. While evidence supports its use in emergency and critical care settings, its efficacy and implementation within routine oncology nursing practice are not well-established. Existing studies in this specific population are limited and of low certainty.

This trial employs a pragmatic, mixed-methods design to evaluate the real-world effectiveness of ultrasound-guided PIVC insertion by trained oncology nurses compared to the standard technique. The embedded qualitative component is critical for understanding the contextual factors influencing implementation, including clinician acceptability and the patient experience, which are vital for guiding future scale-up if the intervention is proven effective.

The intervention involves a structured, competency-based training program for oncology nurses in ultrasound-guided vascular access, developed and delivered by clinical experts at the University of Galway. The program's curriculum is grounded in task analysis and includes supervised clinical practice to ensure procedural competency prior to participant enrollment.

The study is conducted across a spectrum of oncology care settings to enhance the generalizability of the findings. The design accounts for key clinical covariates known to influence insertion success, such as DIVA status, through stratified randomization and adjusted statistical models. Data collection integrates quantitative metrics with in-depth qualitative interviews to provide a comprehensive assessment of the intervention's impact on both clinical outcomes and human factors.

Вмешательства

  • Другое Ultrasound-Guided Peripheral Intravenous Catheter Insertion
    In this arm, PIVC insertion is performed by oncology nurses who have completed a structured ultrasound training program. Nurses use real-time ultrasound imaging to identify and select a suitable vein, guide the advancement of the catheter, and confirm placement. This method contrasts with the standard touch-and-feel approach by incorporating ultrasound technology and specialized nurse training to improve first-time insertion success and reduce complications.
  • Другое Traditional Peripheral Intravenous Catheter Insertion
    PIVC insertion performed by oncology nurses using the conventional touch-and-feel landmark technique, relying on visual inspection and palpation of veins. Represents current standard clinical practice in oncology.

Первичные конечные точки

  • First-time insertion success (FTIS) of peripheral intravenous catheter [Срок оценки: At time of PIVC insertion (single insertion episode; assessed immediately following the procedure)]

Критерии участия

Критерии включения

Adults aged 18 years or older.

Diagnosed with cancer (all cancer sites eligible).

Scheduled to receive systemic anti-cancer therapy (SACT) such as chemotherapy, immunotherapy, or targeted therapies.

Requiring peripheral intravenous catheter (PIVC) insertion for treatment.

Критерии исключения

  • Patients younger than 18 years.

Individuals unable to provide informed consent.

Individuals unable to cooperate with study procedures (e.g., cognitive or physical limitations preventing adherence).

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Открытое
Основная цель
Поддерживающая терапия

Центры проведения

Ирландия · 2 центра
  • Galway University Hospital — Galway
  • Portiuncula University Hospital — Galway

Идентификаторы

NCT: NCT07208175 · Ref: C.A 3374 · CNRA21DUG.

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗