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BELLRICU PROJECT: Precision Medicine in Respiratory Intermediate Care Units

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

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07644637
Acronym
BELLRICU
Enrollment
624
Registered
2026-06-12
Start date
2026-06-10
Completion date
2029-05-30
Last updated
2026-06-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Respiratory Failure (ARF), Intermediate Respiratory Care Unit, Mortality Prediction, Respiratory Precision Medicine, Stratification Risk

Keywords

Acute Respiratory Failure, Non-invasive Respiratory Support, Intermediate Respiratory Care Unit, Intensive Care Unit

Brief 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.

Interventions

None listed

Sponsors

Hospital Universitari de Bellvitge
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
30d -IRCU admission Mortalityday 30 after IRCU admissionMonitoring and assessment mortality at 30-day after IRCU admission

Secondary

MeasureTime frameDescription
30d -hospital discharge Mortalityday 30 after hospital dischargeMonitoring and assessment mortality 30 day after hospital discharge
30d-hospital readmission rateday 30 after hospital dischargeMonitoring and assessment hospital readmission 30 day after hospital discharge
30d-urgent medical consultation rateday 30 after hospital dischargeMonitoring and assessment urgent Medical consultation 30 day after hospital discharge

Countries

Spain

Contacts

CONTACTMercè M GASA, Mercè, Respiratory Physician
mgasa@bellvitgehospital.cat034+932607685
CONTACTMarc M PAREDES, Marc, Respiratory Physician
mparedesi@bellvitgehospital.cat034+932607685
STUDY_CHAIRSalud S SANTOS, Head Respiratory Departm. HUB

Respiratory Department. Hospital Universitari de Bellvitge

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 17, 2026