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

12 juni 2026 bijgewerkt door: 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.

Studie Overzicht

Toestand

Nog niet aan het werven

Conditie

Studietype

Observationeel

Inschrijving (Geschat)

624

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Naam: Mercè M GASA, Mercè, Respiratory Physician
Telefoonnummer: 2758 034+932607685
E-mail: mgasa@bellvitgehospital.cat

Studie Contact Back-up

Naam: Marc M PAREDES, Marc, Respiratory Physician
Telefoonnummer: 2042 034+932607685
E-mail: mparedesi@bellvitgehospital.cat

Studie Locaties

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

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

Volwassen
Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Bemonsteringsmethode

Niet-waarschijnlijkheidssteekproef

Studie Bevolking

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

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat	Maatregel Beschrijving	Tijdsspanne
30d -IRCU admission Mortality Tijdsspanne: day 30 after IRCU admission	Monitoring and assessment mortality at 30-day after IRCU admission	day 30 after IRCU admission

Secundaire uitkomstmaten

Uitkomstmaat	Maatregel Beschrijving	Tijdsspanne
30d -hospital discharge Mortality Tijdsspanne: day 30 after hospital discharge	Monitoring and assessment mortality 30 day after hospital discharge	day 30 after hospital discharge
30d-hospital readmission rate Tijdsspanne: 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 Tijdsspanne: day 30 after hospital discharge	Monitoring and assessment urgent Medical consultation 30 day after hospital discharge	day 30 after hospital discharge

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Hospital Universitari de Bellvitge

Onderzoekers

Studie stoel: Salud S SANTOS, Head Respiratory Departm. HUB, Respiratory Department. Hospital Universitari de Bellvitge

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

10 juni 2026

Primaire voltooiing (Geschat)

10 juli 2026

Studie voltooiing (Geschat)

30 mei 2029

Studieregistratiedata

Eerst ingediend

9 juni 2026

Eerst ingediend dat voldeed aan de QC-criteria