ICU Background Early Awareness for Critical deterioratiON
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: ICU Beacon.
- Кому может быть актуально
- Состояния в реестре: Respiratory Failure, Circulatory Failure, Mortality, Organ Dysfunction. 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
- Швейцария
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
ICU Background Early Awareness for Critical deterioratiON (BEACON)
Обзор
The study will compare ICU sub-units, those with additional support of a clinician awareness system, ICU Beacon, and those receiving the standard of care. The win-ratio composite outcome will be assessed by comparing patients by study group and stratified by APACHE score at admission.
Подробное описание
Single-center, stratified, cluster-randomized (the ICU units will be randomized) crossover analysis with outcome-assessor blinding. The analysis will be conducted in the adult intensive care units (ICUs) of Inselspital, Bern, comprising two distinct ICU units: the Blue and the Yellow ICU Unit. Each unit contains two sub-units, which will serve as the clustering units for randomization. The study follows a two-phase design. In the initial phase, sub-units within each ICU unit will be randomly allocated in a 1:1 ratio to either the additional BEACON scoring group or control group. Patients admitted to sub-units allocated to the BEACON group will receive standard care plus BEACON scores, while those admitted to control group will receive standard care only. After predefined cluster periods, allocations will be swapped between the BEACON and control groups. A wash-out period of two weeks will be observed between swaps to minimize carryover effects. During the wash-out period, no new study patients will be enrolled. Once the swap is complete, only newly admitted patients will be enrolled under the sub-unit's new allocation. Patients still occupying sub-units from the preceding period will be censored from the study at the time of the swap and excluded from outcome analysis beyond that point. The same approach will be applied for patients who will be transferred from one unit to a different unit during the ICU admission for logistical/organizational reasons. Importantly, individual patients will only be exposed to one analysis condition-either the BEACON or control-based on the bed allocation at the time of their admission. Only the sub-units themselves undergo crossover, ensuring temporal balance while maintaining patient-level exposure to a single condition.
Вмешательства
- Другое ICU Beacon
Availability of a proprietary clinician awareness for potential organ deterioration software to treating clinicians (ICU Beacon) in addition to the standard of care.
Первичные конечные точки
- The primary objective is to determine whether BEACON improves ICU sub-unit performance, i.e. reduces total mortality and/or mitigates severity of organ failures in an adult university ICU setting. [Срок оценки: Patient data up to 28 days post admission will be collected to support analysis.]
Вторичные конечные точки (4)
- Time free of circulatory failure and alive at 28 days [Срок оценки: Patient data up to 28 days post admission will be collected to support analysis.]
- Time free of respiratory failure and alive at 28 days [Срок оценки: Patient data up to 28 days post admission will be collected to support analysis.]
- All cause mortality at 28 days [Срок оценки: Patient data up to 28 days post admission will be collected to support analysis.]
- Mean total SOFA score over ICU stay [Срок оценки: Patient data up to 28 days post admission will be collected to support analysis.]
Критерии участия
Критерии включения
- admission to intensive care unit
Критерии исключения
- age < 18 years
- presence of documented refused general consent form (at database closure)
- admission for the sole purpose of dying/organ donation or evaluation of such
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Да
Дизайн исследования
- Модель наблюдения
- Другое
Центры проведения
Швейцария · 1 центр
- Inselspital - Universitätsspital Bern — Bern
Идентификаторы
NCT: NCT07119411 · BASEC 2025-00623