- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07644637
BELLRICU PROJECT: Precision Medicine in Respiratory Intermediate Care Units (BELLRICU)
12. juni 2026 opdateret af: 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.
Studieoversigt
Status
Ikke rekrutterer endnu
Undersøgelsestype
Observationel
Tilmelding (Anslået)
624
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Mercè M GASA, Mercè, Respiratory Physician
- Telefonnummer: 2758 034+932607685
- E-mail: mgasa@bellvitgehospital.cat
Undersøgelse Kontakt Backup
- Navn: Marc M PAREDES, Marc, Respiratory Physician
- Telefonnummer: 2042 034+932607685
- E-mail: mparedesi@bellvitgehospital.cat
Studiesteder
-
-
Barcelona
-
L'Hospitalet de Llobregat, Barcelona, Spanien, 08907
- Respiratory Department. Hospital Universitari de Bellvitge
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-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Ingen
Prøveudtagningsmetode
Ikke-sandsynlighedsprøve
Studiebefolkning
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
Beskrivelse
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
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
30d -IRCU admission Mortality
Tidsramme: day 30 after IRCU admission
|
Monitoring and assessment mortality at 30-day after IRCU admission
|
day 30 after IRCU admission
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
30d -hospital discharge Mortality
Tidsramme: day 30 after hospital discharge
|
Monitoring and assessment mortality 30 day after hospital discharge
|
day 30 after hospital discharge
|
|
30d-hospital readmission rate
Tidsramme: 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
Tidsramme: day 30 after hospital discharge
|
Monitoring and assessment urgent Medical consultation 30 day after hospital discharge
|
day 30 after hospital discharge
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Efterforskere
- Studiestol: Salud S SANTOS, Head Respiratory Departm. HUB, Respiratory Department. Hospital Universitari de Bellvitge
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Anslået)
10. juni 2026
Primær færdiggørelse (Anslået)
10. juli 2026
Studieafslutning (Anslået)
30. maj 2029
Datoer for studieregistrering
Først indsendt
9. juni 2026
Først indsendt, der opfyldte QC-kriterier
9. juni 2026
Først opslået (Faktiske)
12. juni 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
16. juni 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
12. juni 2026
Sidst verificeret
1. juni 2026
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Andre undersøgelses-id-numre
- PR238/24
- RP-BRN-SOCAP-FUCAP Grant 2024 (Andet bevillings-/finansieringsnummer: AJUT A PROJECTES DE RECERCA FUNDACIÓ RAMON PLA-BRN-SOCAP-FUCAP 2024)
- SOCAP Grant 2025 (Andet bevillings-/finansieringsnummer: Beca SOCAP Tema Lliure 2025)
- SEPAR Grant 2025 (Andet bevillings-/finansieringsnummer: Beca SEPAR AYUDAS A LA INVESTIGACIÓN 2025. CATEGORIA: INVESTIGADOR NOVEL)
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