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BELLRICU PROJECT: Precision Medicine in Respiratory Intermediate Care Units

NCT07644637 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 624

Last updated 2026-06-16

No results posted yet for this 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.

Conditions

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

Sponsors & Collaborators

  • Hospital Universitari de Bellvitge

    lead OTHER

Principal Investigators

  • Salud S SANTOS, Head Respiratory Departm. HUB · Respiratory Department. Hospital Universitari de Bellvitge

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-06-10
Primary Completion
2026-07-10
Completion
2029-05-30

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07644637 on ClinicalTrials.gov