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NCT Number: NCT07644637

BELLRICU PROJECT: Precision Medicine in Respiratory Intermediate Care Units

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Respiratory Department. Hospital Universitari de Bellvitge

L'Hospitalet de Llobregat, Barcelona, 08907, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 30d -IRCU admission Mortality

    Time frame: day 30 after IRCU admission

    Monitoring and assessment mortality at 30-day after IRCU admission

Secondary outcomes

  1. 30d -hospital discharge Mortality

    Time frame: day 30 after hospital discharge

    Monitoring and assessment mortality 30 day after hospital discharge

  2. 30d-hospital readmission rate

    Time frame: day 30 after hospital discharge

    Monitoring and assessment hospital readmission 30 day after hospital discharge

  3. 30d-urgent medical consultation rate

    Time frame: day 30 after hospital discharge

    Monitoring and assessment urgent Medical consultation 30 day after hospital discharge

Study contacts

Contact information is provided by the study sponsor or research team.

Marc M PAREDES, Marc, Respiratory Physician

CONTACT

[email protected]

034+932607685 ext. 2042

Mercè M GASA, Mercè, Respiratory Physician

CONTACT

[email protected]

034+932607685 ext. 2758

Sponsors and collaborators

Lead sponsor

Hospital Universitari de Bellvitge

Other

Registry information

Official study title

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

Acronym: BELLRICU

Important dates

Study start
2026
Primary completion
2026
Study completion
2029
First posted
Jun 12, 2026
Registry last updated
Jun 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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