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Набор скоро начнётся NCT07426575

Evaluating the Usability of New Dialysis Bags

Наблюдательное Renal Replacement Therapies

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
Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
Кому может быть актуально
Состояния в реестре: Renal Replacement Therapies. 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
Список центров уточняется — проверьте первичный протокол.
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

Evaluating the Usability of New Dialysis Bags for Continuous Renal Replacement Therapy: A Survey Among ICU Nurses

Обзор

Objective: To compare the usability, efficiency, and ergonomics of new dialysis bags with current bags from the nursing perspective in ICU settings. Study Type: Prospective, single-center observational study. Methods: ICU nurses (126 total) will complete two surveys (pre- and post-implementation) evaluating both dialysis bags.

Подробное описание

Rationale Continuous renal replacement therapy (CRRT) is commonly performed in adult ICUs, using large and heavy dialysate bags that require manual mixing, which can be cumbersome and time-consuming for ICU nurses. These bags are integral to the CRRT procedure but may introduce inefficiencies and safety concerns. With the introduction of newer dialysate bags designed for a lower environmental impact, it is important to evaluate how these new bags compare to the current products in terms of usability. The central question of this study is whether the new dialysis bags offer improved usability, efficiency, and ergonomic benefits for ICU nurses.

Objective(s) assess and compare the usability of the new dialysis bags with the currently used dialysis bags from the nursing perspective. The study will focus on evaluating ease of use, identifying problems encountered during use, and measuring efficiency during CRRT in an ICU setting.

Study type The study is a prospective, single-center research design. The study will be conducted in an ICU setting where nurses will be asked to evaluate the current and new dialysis bags at two time points: pre-implementation (evaluation of current bags) and post-implementation (evaluation of new bags).

Study population The study will include adult ICU nurses with at least 6 months of experience in administering CRRT. A total of 126 nurses (63 evaluating the current bags, 63 evaluating the new bags) will be invited to complete the usability questionnaire.

Methods The study will employ a two-time-point survey design. Nurses will first complete a survey evaluating the current dialysis bags. After approximately two months of using the new bags, a second survey will be conducted to assess the new bags. Both surveys will include Likert-scale questions and open-ended responses, focusing on the usability, safety, and efficiency of the dialysis bags. In the post-implementation survey, a head-to-head comparison will be included to directly compare the old and new bags across key usability domains such as ease of mixing, connection, leakage/contamination risks, changeover time, and ergonomic burden.

Burden and risks The burden on participants will be minimal, as the study involves completing two digital questionnaires (pre- and post-implementation). Participation will not interfere with clinical duties or patient care. There are no physical procedures or medical interventions involved, and the study poses no significant risks to participants.

Recruitment and consent Nurses will be recruited directly from the ICU and informed directly by a member of the research team. Participants will receive an information letter (PIF) describing the study's purpose, procedures, and voluntary nature. Informed consent will be obtained before participation. Participation is voluntary, and nurses may withdraw at any time without consequences for their employment or professional activities.

Первичные конечные точки

  • usability [Срок оценки: 4 months]

Критерии участия

Критерии включения

  • Nurse working in an adult intensive care unit (ICU)
  • Competent in performing continuous renal replacement therapy (CRRT)

Критерии исключения

  • Nurses with less than 6 months of experience in administering CRRT, to ensure sufficient experience for a valid head-to-head comparison with the older dialysis bags.
  • Nurses who are not directly involved in the handling or replacement of dialysis bags during CRRT procedures.

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

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Публикации

  • Colligan L, Potts HW, Finn CT, Sinkin RA. Cognitive workload changes for nurses transitioning from a legacy system with paper documentation to a commercial electronic health record. Int J Med Inform. 2015 Jul;84(7):469-76. doi: 10.1016/j.ijmedinf.2015.03.003. Epub 2015 Mar 22. PMID 25868807
  • Hyzy M, Bond R, Mulvenna M, Bai L, Dix A, Leigh S, Hunt S. System Usability Scale Benchmarking for Digital Health Apps: Meta-analysis. JMIR Mhealth Uhealth. 2022 Aug 18;10(8):e37290. doi: 10.2196/37290. PMID 35980732

Идентификаторы

NCT: NCT07426575 · MEC-2025-0747

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗