BELLRICU PROJECT: Precision Medicine in Respiratory Intermediate Care Units (BELLRICU)

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Mortality Prediction; Acute Respiratory Failure (ARF); Intermediate Respiratory Care Unit; Respiratory Precision Medicine; Stratification Risk

• Study Type: Observational
• Enrollment (Estimated): 624

Contacts and Locations

• Study Contact: Name: Mercè M GASA, Mercè, Respiratory Physician; Phone Number: 2758 034+932607685; Email: mgasa@bellvitgehospital.cat
• Study Contact Backup: Name: Marc M PAREDES, Marc, Respiratory Physician; Phone Number: 2042 034+932607685; Email: mparedesi@bellvitgehospital.cat

Study Locations

• Spain
  • Barcelona
    • L'Hospitalet de Llobregat, Barcelona, Spain, 08907
      • Respiratory Department. Hospital Universitari de Bellvitge

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Study design: prospective longitudinal multi-center study

Study Setting:

• Model construction phase at the coordinator IRCU with 8-bed capacity (extendable to 12-bed capacity from December to march, both included). Six single and 3 double rooms. Centralized monitoring. Non-invasive respiratory suport equipment for each patient. Portable echography and bronchoscopy. Transcutaneous capnography and gasometer inside IRCU. Nurse: patient ratio of 1:4. Physiotherapist: patient ratio of 1:8-12. 24-h medical assistance: two respiratory physicians on call.
• Model external validation phase at the rest of the participating IRCUs having similar services and medical complexity that the coordinator IRCU

Description

Inclusion Criteria:

eligible patients for the study will be those that fulfill any clinical criteria to be admitted at Intermediate Respiratory Care Unit (IRCU) and no exclusion criteria of the study.

*Clinical criteria to be admitted to IRCU: 1. Acute or acute-on-chronic respiratory failure requiring non-invasive respiratory suport (NIRS) (Non-invasive ventilation or high flow nasal cannulae); 2. Neuromuscular patients requiring tracheostomy and ventilation invasive adaptation; 3. 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; 5. 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...; 6. 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...); 7. Respiratory complications after a complex interventional bronchoscopy requiring NIRS and/or strict monitoring: after significant bleeding, bronchial laceration, severe bronchospasm, non-controlled arrhythmia...; 8. Respiratory or/and cardiac intercurrent instability in a patient initially admitted to respiratory conventional ward.

Exclusion Criteria: 1. Patient's express negative to participate in the study; 2. Patient already included in other simultaneous and competitive study; 3. Patient cognitive deterioration that unable him to understand the study.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
30d -IRCU admission Mortality	Monitoring and assessment mortality at 30-day after IRCU admission	day 30 after IRCU admission

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
30d -hospital discharge Mortality	Monitoring and assessment mortality 30 day after hospital discharge	day 30 after hospital discharge
30d-hospital readmission rate	Monitoring and assessment hospital readmission 30 day after hospital discharge	day 30 after hospital discharge
30d-urgent medical consultation rate	Monitoring and assessment urgent Medical consultation 30 day after hospital discharge	day 30 after hospital discharge

Collaborators and Investigators

• Sponsor: Hospital Universitari de Bellvitge
• Investigators: Study Chair: Salud S SANTOS, Head Respiratory Departm. HUB, Respiratory Department. Hospital Universitari de Bellvitge

Study record dates

Study Major Dates

• Study Start (Estimated): June 10, 2026
• Primary Completion (Estimated): July 10, 2026
• Study Completion (Estimated): May 30, 2029

Study Registration Dates

• First Submitted: June 9, 2026
• First Submitted That Met QC Criteria: June 9, 2026
• First Posted (Actual): June 12, 2026

Study Record Updates

• Last Update Posted (Actual): June 12, 2026
• Last Update Submitted That Met QC Criteria: June 9, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: Intensive Care Unit; Acute Respiratory Failure; Non-invasive Respiratory Support; Intermediate Respiratory Care Unit
• Other Study ID Numbers: PR238/24; RP-BRN-SOCAP-FUCAP Grant 2024 (Other Grant/Funding Number: AJUT A PROJECTES DE RECERCA FUNDACIÓ RAMON PLA-BRN-SOCAP-FUCAP 2024); SOCAP Grant 2025 (Other Grant/Funding Number: Beca SOCAP Tema Lliure 2025); SEPAR Grant 2025 (Other Grant/Funding Number: Beca SEPAR AYUDAS A LA INVESTIGACIÓN 2025. CATEGORIA: INVESTIGADOR NOVEL)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No