Набор скоро начнётся NCT07141134

Turnova: The Clinical Efficacy, Manpower Reduction, and Cost-Effectiveness of Turn-Assist Alternating Pressure Air Mattresses for Pressure Injury Prevention in the ICU

Без фазы С лечением Critical Care, Intensive Care Nursing Workload Cost Analysis

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: TAPAM, HSFM, Manual Turning (with pillows, per protocol), Positioning Pillows.
Кому может быть актуально: Состояния в реестре: Critical Care, Intensive Care, Nursing Workload, Cost Analysis. Базовые параметры: от 18 лет · 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: Тайвань
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Не всё понятно в терминах? Прочитайте наш гид для пациентов →

Обзор

Pressure injuries are common in intensive care unit (ICU) patients who cannot reposition themselves. International guidelines recommend using support surfaces to redistribute pressure and regular turning to prevent these injuries. In Taiwan, high-specification foam mattresses (HSFM) with manual turning remain the standard, but frequent repositioning is labor-intensive and challenging in settings with limited nursing staff. The Turn-Assist Alternating Pressure Air Mattress (TAPAM) integrates pressure redistribution with automated lateral turning, potentially reducing nursing workload while maintaining preventive effectiveness. This study will compare TAPAM with HSFM plus manual turning in ICU patients, evaluating manpower requirements, time spent, perceived effort, and clinical outcomes. A cost-effectiveness and cost-benefit analysis will be conducted to assess the overall value of TAPAM for pressure injury prevention in high-risk ICU populations.

Подробное описание

This prospective comparative study will be conducted in the ICUs of a tertiary medical center in Taiwan. Adult patients at high risk for pressure injury and requiring assistance for repositioning will be enrolled and assigned to one of two interventions: (1) TAPAM, providing alternating pressure relief and programmed lateral turning, or (2) HSFM with manual repositioning according to standard ICU protocol.

Primary outcomes include manpower feasibility (number of staff required, time per turning) and clinical effectiveness (incidence of new pressure injuries). Secondary outcomes include economic indicators such as equipment costs, labor cost savings, and overall cost-effectiveness.

Economic evaluation will be performed from the hospital perspective, incorporating both direct costs (equipment, supplies, labor) and indirect savings from prevented injuries. Results will provide real-world evidence on whether TAPAM can improve care efficiency, reduce staff workload, and deliver cost-effective pressure injury prevention in high-dependency ICU settings.

Вмешательства

Устройство TAPAM
Device: Turn-Assist Alternating Pressure Air Mattress (TAPAM) Automated lateral turning with pressure redistribution.
Устройство HSFM
Device: High-Specification Foam Mattress (HSFM) Standard ICU care support surface.
Другое Manual Turning (with pillows, per protocol)
Nurse-performed scheduled manual turning (target every 2 hours, with pillows).
Другое Positioning Pillows
Supplemental pillows used to support and maintain patient position.

Первичные конечные точки

Manpower requirements for turning and positioning [Срок оценки: Through ICU stay, up to 30 days (average per patient).]
Time spent on turning and positioning [Срок оценки: Through ICU stay, up to 30 days (average per patient).]
Perceived exertion of turning task [Срок оценки: Through ICU stay, up to 30 days (average per patient).]

Вторичные конечные точки (10)

Incidence of new pressure injuries [Срок оценки: From ICU admission through ICU discharge (up to 30 days).]
Pressure injury incidence density [Срок оценки: From ICU admission through ICU discharge (up to 30 days).]
Pressure injury deterioration rate [Срок оценки: From ICU admission through ICU discharge (up to 30 days).]
Pressure injury deterioration density [Срок оценки: From ICU admission through ICU discharge (up to 30 days).]
Economic evaluation: Total care costs [Срок оценки: Through study completion, up to 30 days after ICU discharge.]
Pressure injury-free days [Срок оценки: From ICU admission through ICU discharge (up to 30 days).]
Economic evaluation:Labor costs [Срок оценки: From ICU admission through ICU discharge (up to 30 days).]
Economic evaluation:Equipment costs [Срок оценки: Through study completion, up to 30 days after ICU discharge.]
Economic evaluation: Cost-effectiveness ratio [Срок оценки: Through study completion, up to 30 days after ICU discharge.]
Economic evaluation : Cost-benefit ratio [Срок оценки: Through study completion, up to 30 days after ICU discharge]

Критерии участия

Критерии включения

Adult patients (≥18 years old) admitted to medical or surgical intensive care units (ICUs).
Admission time between 08:00 and 23:00.
Clinical condition requires ICU-level care.