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

12 juni 2026 uppdaterad av: 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.

Studieöversikt

Status

Har inte rekryterat ännu

Betingelser

Studietyp

Observationell

Inskrivning (Beräknad)

624

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

Namn: Mercè M GASA, Mercè, Respiratory Physician
Telefonnummer: 2758 034+932607685
E-post: mgasa@bellvitgehospital.cat

Studera Kontakt Backup

Namn: Marc M PAREDES, Marc, Respiratory Physician
Telefonnummer: 2042 034+932607685
E-post: mparedesi@bellvitgehospital.cat

Studieorter

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

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

Vuxen
Äldre vuxen

Tar emot friska volontärer

Nej

Testmetod

Icke-sannolikhetsprov

Studera befolkning

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

Beskrivning

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.

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

Vad mäter studien?

Primära resultatmått

Resultatmått	Åtgärdsbeskrivning	Tidsram
30d -IRCU admission Mortality Tidsram: day 30 after IRCU admission	Monitoring and assessment mortality at 30-day after IRCU admission	day 30 after IRCU admission

Sekundära resultatmått

Resultatmått	Åtgärdsbeskrivning	Tidsram
30d -hospital discharge Mortality Tidsram: day 30 after hospital discharge	Monitoring and assessment mortality 30 day after hospital discharge	day 30 after hospital discharge
30d-hospital readmission rate Tidsram: 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 Tidsram: day 30 after hospital discharge	Monitoring and assessment urgent Medical consultation 30 day after hospital discharge	day 30 after hospital discharge

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Hospital Universitari de Bellvitge

Utredare

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

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Beräknad)

10 juni 2026

Primärt slutförande (Beräknad)

10 juli 2026

Avslutad studie (Beräknad)

30 maj 2029

Studieregistreringsdatum

Först inskickad

9 juni 2026

Först inskickad som uppfyllde QC-kriterierna