BELLRICU PROJECT: Precision Medicine in Respiratory Intermediate Care Units

NCT07644637 | Not Yet Recruiting DMC

• 4 other identifiers: PR238/24RP-BRN-SOCAP-FUCAP Grant 2024SOCAP Grant 2025SEPAR Grant 2025
• Study Type: observational
• Target: 624
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 30d -IRCU admission Mortality

  Monitoring and assessment mortality at 30-day after IRCU admission

  day 30 after IRCU admission

Secondary Outcomes (3)

• 30d -hospital discharge Mortality

  day 30 after hospital discharge

• 30d-hospital readmission rate

  day 30 after hospital discharge

• 30d-urgent medical consultation rate

  day 30 after hospital discharge

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may not qualify if:

• \*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.

Sponsors & Collaborators

• Hospital Universitari de Bellvitge: lead

Study Sites (1)

Respiratory Department. Hospital Universitari de Bellvitge

L'Hospitalet de Llobregat, Barcelona, 08907, Spain

Location

Study Officials

• Salud S SANTOS, Head Respiratory Departm. HUB

  Respiratory Department. Hospital Universitari de Bellvitge

  STUDY CHAIR

Central Study Contacts

Mercè M GASA, Mercè, Respiratory Physician

CONTACT

034+932607685; mgasa@bellvitgehospital.cat

Marc M PAREDES, Marc, Respiratory Physician

CONTACT

034+932607685; mparedesi@bellvitgehospital.cat

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 30 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Respiratory Physician; M.D.; PhD; Associated Prof

Study Record Dates

• First Submitted: June 9, 2026
• First Posted: June 12, 2026
• Study Start: June 10, 2026
• Primary Completion (Estimated): July 10, 2026
• Study Completion (Estimated): May 30, 2029
• Last Updated: June 12, 2026

Record last verified: 2026-06

Locations

ES (1)