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

12 juin 2026 mis à jour par: Mercè Gasa Galmes, Hospital Universitari de Bellvitge

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.

Aperçu de l'étude

Statut

Pas encore de recrutement

Les conditions

Type d'étude

Observationnel

Inscription (Estimé)

624

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Nom: Mercè M GASA, Mercè, Respiratory Physician
Numéro de téléphone: 2758 034+932607685
E-mail: mgasa@bellvitgehospital.cat

Sauvegarde des contacts de l'étude

Nom: Marc M PAREDES, Marc, Respiratory Physician
Numéro de téléphone: 2042 034+932607685
E-mail: mparedesi@bellvitgehospital.cat

Lieux d'étude

Espagne
- Barcelona
  - L'Hospitalet de Llobregat, Barcelona, Espagne, 08907
    - Respiratory Department. Hospital Universitari de Bellvitge

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

Adulte
Adulte plus âgé

Accepte les volontaires sains

Non

Méthode d'échantillonnage

Échantillon non probabiliste

Population étudiée

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

La description

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.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats	Description de la mesure	Délai
30d -IRCU admission Mortality Délai: day 30 after IRCU admission	Monitoring and assessment mortality at 30-day after IRCU admission	day 30 after IRCU admission

Mesures de résultats secondaires

Mesure des résultats	Description de la mesure	Délai
30d -hospital discharge Mortality Délai: day 30 after hospital discharge	Monitoring and assessment mortality 30 day after hospital discharge	day 30 after hospital discharge
30d-hospital readmission rate Délai: day 30 after hospital discharge	Monitoring and assessment hospital readmission 30 day after hospital discharge	day 30 after hospital discharge
30d-urgent medical consultation rate Délai: day 30 after hospital discharge	Monitoring and assessment urgent Medical consultation 30 day after hospital discharge	day 30 after hospital discharge

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Hospital Universitari de Bellvitge

Les enquêteurs

Chaise d'étude: Salud S SANTOS, Head Respiratory Departm. HUB, Respiratory Department. Hospital Universitari de Bellvitge

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Estimé)

10 juin 2026

Achèvement primaire (Estimé)

10 juillet 2026

Achèvement de l'étude (Estimé)

30 mai 2029

Dates d'inscription aux études

Première soumission

9 juin 2026

Première soumission répondant aux critères de contrôle qualité