- ICH GCP
- Реестр клинических исследований США
- Клиническое испытание NCT07703618
Evaluation of Proximal Massage and Palm-to-Fist Tapping on Reducing the Risk of Phlebitis
Evaluation of the Effect of Proximal Massage and Palm-to-Fist Tapping on Reducing the Risk of Phlebitis Associated With Peripheral Venous Catheter Insertion
Обзор исследования
Статус
Условия
Подробное описание
Peripheral venous catheter insertion is a common clinical procedure performed in a substantial proportion of hospitalized patients. It is estimated that between 58.7% and 86.7% of hospitalized patients require a peripheral venous catheter during their hospital stay, and, ideally, catheter dwell time should not exceed six days. Indications for peripheral venous catheterization are diverse and include hemodynamic monitoring, intravenous administration of fluids and medications, blood transfusions, and the administration of contrast media for diagnostic imaging procedures.
Despite being a routine and relatively simple procedure, complications associated with peripheral venous catheter use continue to represent an important public health concern because they are associated with prolonged hospital stays, delayed patient discharge, and increased healthcare costs. The most common complications include phlebitis, infiltration, ecchymosis, extravasation, and embolism. These complications may occur while the catheter remains in place or even up to 96 hours after catheter removal. Therefore, given the widespread use of peripheral venous catheters and the potentially deleterious consequences of these complications, appropriate catheter management and care are essential to reduce their incidence.
Phlebitis is defined as inflammation of the venous intima and is clinically characterized by local inflammatory signs, including erythema, edema, and pain. Reported incidence rates range from 2% to 80%, depending largely on the control of modifiable risk factors. Three major categories of risk factors have been associated with the development of phlebitis. The first comprises patient-related factors, including age, sex, and pre-existing medical conditions. The second includes chemical factors, primarily related to the dose and osmolarity of intravenously administered medications. The third encompasses mechanical factors, such as catheter size, insertion site, and catheter material.
Several types of phlebitis have been described, each associated with different risk factors. Mechanical phlebitis is related to catheter size and material, inadequate catheter stabilization that facilitates catheter movement and subsequent irritation of the vascular wall, and catheter placement near a joint. Bacterial phlebitis develops as a consequence of poor aseptic technique or prolonged catheter dwell time. Finally, chemical phlebitis is associated with the characteristics of the cannulated vein and the type of infused solution, particularly highly acidic or alkaline solutions.
Тип исследования
Регистрация (Оцененный)
Фаза
- Непригодный
Контакты и местонахождение
Контакты исследования
- Имя: Sandra Valderrama, Dra
- Номер телефона: 6932 +57(601) 594616
- Электронная почта: svalderrama.med@javeriana.edu.co
Места учебы
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Bogota D.C.
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Bogotá, Bogota D.C., Колумбия
- Рекрутинг
- Hospital Universitario San Ignacio
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Контакт:
- Sandra Valderrama, Dra.
- Номер телефона: 6932 +57 (601) 5946161
- Электронная почта: slvalderrama@husi.org.co
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Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
- Взрослый
- Пожилой взрослый
Принимает здоровых добровольцев
Описание
Inclusion Criteria:
a. Eligible participants will be adults aged 18 years or older who have had a PIVC inserted into an upper extremity within the previous 24 hours and are expected to require peripheral intravenous access for at least 48 hours.
Exclusion Criteria:
a.Patients will be excluded if they have impaired consciousness, critical illness precluding participation in the intervention, physical limitations preventing performance of the prescribed exercises, anatomical or functional abnormalities of the catheterized upper extremity, or if adequate clinical follow-up cannot be ensured.
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Профилактика
- Распределение: Рандомизированный
- Интервенционная модель: Последовательное назначение
- Маскировка: Нет (открытая этикетка)
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
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Плацебо Компаратор: Estandard peripheral venous catheter care protocol
Participants assigned to the control group will receive the standard peripheral venous catheter care protocol implemented at Hospital Universitario San Ignacio
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control group will receive the standard peripheral venous catheter care protocol implemented
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Экспериментальный: Effect of proximal massage and palm-to-fist tapping
The intervention will consist of two non-pharmacological components.
Following hand hygiene, participants will receive gentle massage using the palmar surface of the fingers over an area located approximately 2-3 cm proximal to the peripheral intravenous catheter insertion site.
Each session will last approximately 2-3 minutes and will be performed three times daily for up to four consecutive days or until catheter removal, whichever occurs first.
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Following hand hygiene, participants will receive gentle massage using the palmar surface of the fingers over an area located approximately 2-3 cm proximal to the peripheral intravenous catheter insertion site.
Each session will last approximately 2-3 minutes and will be performed three times daily for up to four consecutive days or until catheter removal, whichever occurs first
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Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Incidence of phlebitis during the observation period
Временное ограничение: Participants will be followed for 4 days (96 hours) after catheter insertion. Outcome assessments will be performed at 24, 48, 72, and 96 hours.
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To evaluate the effect of proximal massage and palm-to-fist tapping exercises on reducing the risk of peripheral venous catheter-related phlebitis during the first 96 hours after catheter insertion
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Participants will be followed for 4 days (96 hours) after catheter insertion. Outcome assessments will be performed at 24, 48, 72, and 96 hours.
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Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
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Time to first episode of phlebitis, maximum phlebitis severity during follow-up and evaluate factors associated with the development of phlebitis
Временное ограничение: Participants will be followed for 4 days (96 hours) after catheter insertion. Outcome assessments will be performed at 24, 48, 72, and 96 hours.
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Participants assigned to the intervention group will receive standardized instruction from the study investigators and will be encouraged
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Participants will be followed for 4 days (96 hours) after catheter insertion. Outcome assessments will be performed at 24, 48, 72, and 96 hours.
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Соавторы и исследователи
Следователи
- Главный следователь: Ángel García, Dr, Hospital Universitario San Ignacio
Публикации и полезные ссылки
Общие публикации
- Heng SY, Yap RT, Tie J, McGrouther DA. Peripheral Vein Thrombophlebitis in the Upper Extremity: A Systematic Review of a Frequent and Important Problem. Am J Med. 2020 Apr;133(4):473-484.e3. doi: 10.1016/j.amjmed.2019.08.054. Epub 2019 Oct 10.
- Cihan Erdoğ an B, Zehra GB. Nursing initiatives in peripheral intravenous catheter re- lated flebit and preventıon. Gazi J Heal Sci 2020;5:30-36
- Ozturk D, Erdogan BC, Dogan N, Kiziltepe K, Baykara ZG. Phlebitis related to peripheric intravenous catheter: A point prevalence study. J Ankara Univ Fac Med 2021;74:310-316
- Lv L, Zhang J. The incidence and risk of infusion phlebitis with peripheral intravenous catheters: A meta-analysis. J Vasc Access. 2020 May;21(3):342-349. doi: 10.1177/1129729819877323. Epub 2019 Sep 23.
Даты записи исследования
Изучение основных дат
Начало исследования (Действительный)
Первичное завершение (Действительный)
Завершение исследования (Оцененный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- 2024/293
Планирование данных отдельных участников (IPD)
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Описание плана IPD
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
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