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Набор скоро начнётся NCT07644637

BELLRICU PROJECT: Precision Medicine in Respiratory Intermediate Care Units

— Наблюдательное Acute Respiratory Failure (ARF) Intermediate Respiratory Care Unit Respiratory Precision Medicine Mortality Prediction

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: Acute Respiratory Failure (ARF), Intermediate Respiratory Care Unit, Respiratory Precision Medicine, Mortality Prediction. 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
Испания
Следующий шаг
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Официальное название

BELLRICU PROJECT: Precision Medicine in Respiratory Intermediate Care Units. Improvement of Risk Stratification, Mortality Prediction and clínical Decision-making (UCRI-CAT Team).

Обзор

A respiratory intermediate care unit (RICU) is a monitoring and treatment area of respiratory patients who do not required admission to intensive care unit (ICU) but due to complexity, they could not be managed in conventional ward. Aim: To investigate those patients that could better benefit from RICU stay. Hypothesis: a comprehensive and integrative knowledge of all factors that intervene during the RICU admission allow determining probability of survival. Primary outcome: 1. To construct a predictive model of mortality at 30-days after RICU admission for patients admitted to the coordinator RICU based on standard biostatistics: The BELLRICU Model. Secondary outcomes: 2.1. To validate the model in another cohort of patients admitted at the same RICU. 2.2. To validate the model in an external cohort (patients admitted at the rest of Catalan active RICUs at the time of the study). 2.3. To compare the predictive capacity of the BELLRICU model with other previous validated scales but in ICU setting. 2. 4. To explore a new predictive model using artificial intelligence (AI) techniques. 2.4. To design a quick app to implement the BELLRICU model. Methodology: Longitudinal prospective study (3 years), recording variables at baseline, at RICU admission and 30-days follow-up. During the first two years, variables will be collected from the coordinator RICU to construct the BELLRICU model, being "mortality after 30-day of RICU admission" the dependent varialbe and using regression of cox proportional risks analysis. During the third year of the study, the BELLRICU model will be applicated to the rest of the participants RICUs in order to validate the model. Further, the predictive capacity of the BELLRICU model will be compared with the predictive capacity of previous validated scales in ICU setting and with a exploratory model using AI from BELLRICU data base.

Первичные конечные точки

  • 30d -IRCU admission Mortality [Срок оценки: day 30 after IRCU admission]
Вторичные конечные точки (3)
  • 30d -hospital discharge Mortality [Срок оценки: day 30 after hospital discharge]
  • 30d-hospital readmission rate [Срок оценки: day 30 after hospital discharge]
  • 30d-urgent medical consultation rate [Срок оценки: day 30 after hospital discharge]

Критерии участия

Критерии включения

  • Acute or acute-on-chronic respiratory failure requiring non-invasive respiratory suport (NIRS) (Non-invasive ventilation or high flow nasal cannulae)
  • Neuromuscular patients requiring tracheostomy and ventilation invasive adaptation
  • Life-treating hemoptysis requiring emergent or urgent bronchial embolization (<24 hours)
  • 4\. Pulmonary embolism of high-intermediate risk requiring monitoring during first 24-48h of hospital admission on anticoagulation
  • Patients derived from Intensive care unit (ICU) requiring intermediate Medical step before transferred safely to conventional ward (complex respiratory weaning from invasive ventilation, high-dependency nurse cures due to limiting post-critical myopathy
  • Patients with thoracic cancer (onset or complication) of vital risk (major hemoptysis, massive pleural effusion, pericardial effusion on pre or cardiac arrest, pneumonitis related to oncological treatment with severe acute respiratory failure requiring NIRS, cava vein syndrome requiring emergent prothesis, etc...)
  • Respiratory complications after a complex interventional bronchoscopy requiring NIRS and/or strict monitoring: after significant bleeding, bronchial laceration, severe bronchospasm, non-controlled arrhythmia
  • Respiratory or/and cardiac intercurrent instability in a patient initially admitted to respiratory conventional ward.

Критерии исключения

  • Patient's express negative to participate in the study
  • Patient already included in other simultaneous and competitive study
  • Patient cognitive deterioration that unable him to understand the study.

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Испания · 1 центр
  • Respiratory Department. Hospital Universitari de Bellvitge — L'Hospitalet de Llobregat

Идентификаторы

NCT: NCT07644637 · PR238/24 · RP-BRN-SOCAP-FUCAP Grant 2024 · SOCAP Grant 2025 · SEPAR Grant 2025

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗