- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07644637
BELLRICU PROJECT: Precision Medicine in Respiratory Intermediate Care Units (BELLRICU)
BELLRICU PROJECT: Precision Medicine in Respiratory Intermediate Care Units. Improvement of Risk Stratification, Mortality Prediction and clínical Decision-making (UCRI-CAT Team).
Studieoversigt
Status
Undersøgelsestype
Tilmelding (Anslået)
Kontakter og lokationer
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
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Barcelona
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L'Hospitalet de Llobregat, Barcelona, Spanien, 08907
- Respiratory Department. Hospital Universitari de Bellvitge
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Prøveudtagningsmetode
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:
eligible patients for the study will be those that fulfill any clinical criteria to be admitted at Intermediate Respiratory Care Unit (IRCU) and no exclusion criteria of the study.
*Clinical criteria to be admitted to IRCU: 1. Acute or acute-on-chronic respiratory failure requiring non-invasive respiratory suport (NIRS) (Non-invasive ventilation or high flow nasal cannulae); 2. Neuromuscular patients requiring tracheostomy and ventilation invasive adaptation; 3. 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; 5. 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...; 6. 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...); 7. Respiratory complications after a complex interventional bronchoscopy requiring NIRS and/or strict monitoring: after significant bleeding, bronchial laceration, severe bronchospasm, non-controlled arrhythmia...; 8. Respiratory or/and cardiac intercurrent instability in a patient initially admitted to respiratory conventional ward.
Exclusion Criteria: 1. Patient's express negative to participate in the study; 2. Patient already included in other simultaneous and competitive study; 3. Patient cognitive deterioration that unable him to understand the study.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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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
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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
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Monitoring and assessment hospital readmission 30 day after hospital discharge
|
day 30 after hospital discharge
|
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30d-urgent medical consultation rate
Tidsramme: day 30 after hospital discharge
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Monitoring and assessment urgent Medical consultation 30 day after hospital discharge
|
day 30 after hospital discharge
|
Samarbejdspartnere og efterforskere
Efterforskere
- Studiestol: Salud S SANTOS, Head Respiratory Departm. HUB, Respiratory Department. Hospital Universitari de Bellvitge
Datoer for undersøgelser
Studer store datoer
Studiestart (Anslået)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
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)
Plan for individuelle deltagerdata (IPD)
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