BELLRICU PROJECT: Precision Medicine in Respiratory Intermediate Care Units

NCT07644637 · tracked via the Priya Life Science Spain tracker

Sponsor

Hospital Universitari de Bellvitge

Phase

Observational

Started

2026-06-10

Last updated

2026-06-16

Condition(s) studied

Acute Respiratory Failure (ARF)Intermediate Respiratory Care UnitRespiratory Precision MedicineMortality PredictionStratification Risk

Study summary

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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

Inclusion Criteria: * 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. Exclusion Criteria: * 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.

Primary outcome measure(s)

30d -IRCU admission Mortality — day 30 after IRCU admission
Monitoring and assessment mortality at 30-day after IRCU admission

Trial sites (1)

Facility	City	Region	Status
Respiratory Department. Hospital Universitari de Bellvitge	L'Hospitalet de Llobregat	Barcelona

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07644637 on ClinicalTrials.gov ↗ ← All trials in Spain